USFDA

Strides Pharma Science Limited (Strides) stated that its wholly-owned step-down subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured the approval of the United States Food & Drug Administration (USFDA) for Prednisone Tablets USP, 1 mg. These tablets are a generic version of Schering Corporation’s Meticorten Tablets, 1 mg.

As per the IQVIA MAT July 2020 figures, the US market ranges up to USD 12 million for Prednisone Tablets USP, 1 mg. According to the company’s press release, the manufacturing of the tablet will take place at the flagship facility of the company at Bengaluru. The tablets will be sold in the US market by Strides Pharma Inc. 

Recently on August 21, 2020, Strides Pharma Science Limited got the USFDA approval for Ursodiol Tablets USP, 250 mg and 500 mg also. During February, Strides’ wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, signed a comprehensive asset transfer and licensing agreement with Pharmaceutics International, Inc. to obtain 18 ANDAs from the company for the US market. Strides aim to expand its niche offerings significantly on its front end, that will lead to multi fold growth in the upcoming years.

As per the consolidated unaudited financial reports of the company for the quarter ended June 30, 2020, the company’s total income was INR 7,941.02 million as compared to the INR 6,960.52 million of the corresponding quarter of the previous year. The profit before tax for the above-mentioned quarter stands at INR 1,051.25 million which is much higher than INR 248.84 million of the corresponding quarter of the previous year.

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Baxter International Inc a global innovator in renal care, announced the U.S. Food and Drug Administration (FDA) has granted the De Novo application for Theranova, the company’s novel dialysis membrane. Theranova was designed to deliver expanded hemodialysis (HDx) therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters, like high-flux membranes, by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa). These middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.

By granting a De Novo application, the FDA is establishing a new class of dialyzer technology with unique performance standards. The FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such designations are rare in the dialysis space. In fact, less than 1% of devices granted marketing authorization under De Novo have been for the care of patients with kidney failure since the pathway’s inception in 1997.

HDx is performed the same way as conventional HD, with only a change of the dialyzer membrane required. Once in the machine, the Theranova dialyzer’s innovative Medium Cut-Off® membrane combines high permeability and selectivity for uremic toxins (up to 45 kDa), while retaining essential proteins and maintaining albumin levels during treatment2,3. This unique cut-off and high retention onset profile expands clearance, allowing for filtration closer to that of the natural kidney.

"U.S. patients on HD deserve more options than are currently available to them, and we are taking extraordinary steps to support their access to Theranova," said Gavin Campbell, general manager of Baxter's U.S. Renal Care business. "Patients are currently treated with HDx enabled by Theranova in more than 40 countries worldwide, and we are doing everything we can in the U.S. to ensure healthcare providers can also realize the full value of this therapy for their patients on HD."

To date, over 90 independent and Baxter-led or sponsored studies have been conducted on HDx therapy enabled by Theranova. The studies evaluated a range of clinical and quality-of-life measures, including the ability to clear conventional and large middle molecules, albumin retention, chronic inflammation and other side effects of standard HD therapy.

"Individually, the side effects from standard HD, which patients typically undertake three days a week, four hours per day, may seem manageable. However, the chronic effects of treatment accumulate and over time, cause some patients to give up on therapy," explained Mary Gellens, M.D., nephrologist and senior medical director at Baxter. "HDx therapy enabled by Theranova is a promising alternative to what is currently available because it delivers a filtration profile that is closer to the natural kidney."

Due to the novel nature of Theranova, Baxter conducted a randomized controlled clinical study in the United States that evaluated the safety and efficacy of HDx therapy enabled by Theranova. During the study, as reported during the 2019 American Society of Nephrology Kidney Week, 172 hemodialysis patients received therapy with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (ELISIO-17H) over 24 weeks of treatment, with a primary efficacy endpoint measuring the reduction ratio of lambda (λ) free light chains at 24 weeks of treatment, while maintaining pre-dialysis serum albumin levels. Data from the study, which was just published in the Clinical Journal of the American Society of Nephrology (CJASN), found that expanded hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of large middle molecules, as exemplified by λ free light chains, as compared to a similarly sized high flux dialyzer while maintaining serum albumin levels7. Large middle molecules are a diverse group of uremic toxins that are believed to contribute to the high cardiovascular disease burden in end stage kidney disease8. Dialysis technologies available to date offer limited clearance of these molecules8. The ability to efficiently remove these large middle molecules provides dialysis patients with a new alternative therapy.

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Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. For this reason, the discovery of unexpected nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply. As we do so, we’re also taking proactive efforts to help ensure that in the future, drugs can be free from unsafe levels of these impurities from the start of production.

Ensuring that drugs are safe, effective and high-quality is a critical part of FDA’s mission. In our continued efforts to be transparent and provide guidance to manufacturers on how to detect and prevent unacceptable levels of nitrosamine impurities, today we’re publishing our guidance Control of Nitrosamine Impurities in Human Drugs for immediate implementation. This guidance recommends steps, including a comprehensive risk assessment strategy and other actions that manufacturers can take to reduce or prevent the presence of nitrosamine impurities in their drugs.

There are many reasons why these impurities might appear in some drugs, and consequently many approaches to screening for and preventing the appearance of nitrosamines to help ensure drug quality and safety. The source of these impurities can be related to the drug’s manufacturing process, the materials used in manufacturing, the drugs’ chemical structure, or even the conditions in which drugs are stored or packaged. Under FDA’s oversight, manufacturers are responsible for mitigating these impurities.

The most common nitrosamine impurity, N-nitrosodimethylamine (NDMA), is found at low levels in water and foods, including cured and grilled meats, dairy products and vegetables. The FDA and the international scientific community do not expect NDMA to cause harm when ingested at low levels. However, given the risk that genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above certain levels and over long periods of time, manufacturers have recalled drugs with NDMA levels higher than the FDA’s recommended acceptable intake levels. Patients taking medications with potential nitrosamine impurities should not stop taking their medications and should talk with their health care professional about concerns and other treatment options.

We believe that the guidance we’ve issued today will assist manufacturers in preventing unacceptable levels of nitrosamines in drugs. Protecting patients is the FDA’s highest priority, and we will continue to work with manufacturers and our international regulatory partners to investigate and definitively resolve this problem.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.

The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.

Alex Azar, Health and Human Services Secretary:
“The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” said Secretary Azar. “The Trump Administration recognized the potential of convalescent plasma early on. Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials. Our work on convalescent plasma has delivered broader access to the product than is available in any other country and reached more than 70,000 American patients so far. We are deeply grateful to Americans who have already donated and encourage individuals who have recovered from COVID-19 to consider donating convalescent plasma.”

Stephen M. Hahn, M.D., FDA Commissioner:
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said Dr. Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”

Scientific Evidence on Convalescent Plasma
Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met.

The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.

The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma. The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence.

Terms of EUA
The EUA requires that fact sheets providing important information about using COVID-19 convalescent plasma in treating COVID-19 be made available to health care providers and patients, including dosing instructions and potential side effects. Possible side effects of COVID-19 convalescent plasma include allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.

Mayo Clinic Expanded Access Program
The FDA initially facilitated access to convalescent plasma for treating COVID-19 by using pathways that included traditional clinical trials and emergency single-patient investigational new drug (IND) applications.

An Expanded Access ProgramExternal Link Disclaimer for convalescent plasma was initiated in early April to fill an urgent need to provide patient access to a medical product of possible benefit during a time that the FDA was working with researchers to facilitate the initiation of randomized clinical trials to study convalescent plasma. As the number of single patient IND requests started to number in the hundreds on a daily basis, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol. The program was developed with funding from the HHS’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. To date, the program has facilitated the infusion of over 70,000 patients with convalescent plasma.

The EUA was issued to the HHS Office of the Assistant Secretary for Preparedness and Response.

The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19. The EUA may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Strides Pharma Science Limited (Strides) announced that its step down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg from the United States Food & Drug Administration (USFDA).

The product is a generic version of Fioricet® with Codeine Capsules, 50 mg/325 mg/40 mg/30 mg, of Teva Branded Pharmaceutical Product R&D, Inc.

According to IQVIA MAT May 2020 data, the US market for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg is approximately US$ 10 Mn. The product will be marketed by Strides Pharma Inc. in the US market.

The company has 124 cumulative ANDA filings with USFDA of which 87 ANDAs have been approved and 37 are pending approval.

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Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

The approval is based on results from the Phase III JAVELIN Bladder 100 study, which demonstrated a significant 7.1-month improvement in median overall survival (OS) with BAVENCIO as first-line maintenance plus best supportive care (BSC) compared with BSC alone: 21.4 months (95% CI: 18.9 to 26.1) vs. 14.3 months (95% CI: 12.9 to 17.9). This statistically significant improvement in OS represents a 31% reduction in the risk of death in the overall population (HR 0.69; 95% CI: 0.56 to 0.86; 2-sided P=0.001).1 OS was measured from the time of randomization, after patients were treated with four to six cycles of gemcitabine plus cisplatin or carboplatin over a period of approximately four months. The JAVELIN Bladder 100 results were presented at the ASCO 2020 Virtual Scientific Meeting.

“As the first immunotherapy to demonstrate a statistically significant improvement in overall survival in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years,” said Petros Grivas, M.D., Ph.D., one of the principal investigators in the JAVELIN Bladder 100 trial. “With median overall survival of more than 21 months, measured from randomization, the longest overall survival in a Phase III trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease.”

Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates. However, most patients will ultimately experience disease progression within nine months of initiation of treatment,3,4 and only 5% of patients with metastatic disease at diagnosis will live longer than five years.

“Many patients newly diagnosed with advanced urothelial carcinoma receive benefit from initial chemotherapy, but we still need treatment options that can help patients live longer,” said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network. “We wholeheartedly support the development of new and promising treatments like BAVENCIO that can offer patients and their loved ones hope.”

For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.

The FDA previously approved BAVENCIO under the accelerated approval program in 2017 for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, based on tumor response rate and duration of response. Continued approval was contingent upon verification of clinical benefit, which was demonstrated in JAVELIN Bladder 100. The FDA has now converted the accelerated approval to full approval.

“Today’s approval of BAVENCIO in the most common type of advanced bladder cancer underscores our commitment to advancing scientific innovation and transforming outcomes for people with genitourinary cancers,” said Andy Schmeltz, Global President, Pfizer Oncology.

“With this approval for BAVENCIO, we have the opportunity to fundamentally shift the standard of care in the first-line setting of advanced bladder cancer. Our focus now is to work closely with the GU community to ensure that this novel and potentially life-changing treatment paradigm is rapidly integrated into clinical practice,” said Rehan Verjee, President of North America and Global Head of Innovative Medicine Franchises for the Biopharma business of Merck.

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Biocon Ltd an innovation-led global biopharmaceuticals company, announced that its subsidiary Biocon Biologics has received the Drugs Controller General of India’s (DCGI) approval for an extracorporeal blood purification (EBP) device CytoSorb® to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

Biocon Biologics has been granted licence for emergency use of CytoSorb in public interest by the Indian health regulator to treat COVID-19 patients who are 18 years of age or older. The licence will be effective until control of the COVID-19 outbreak in the country.

Studies have shown that COVID-19 patients who develop serious complications experience a ‘cytokine storm,’ also known as Cytokine Release Syndrome (CRS), which leads to excessive inflammation, organ failure and death. The goal of CytoSorb therapy is to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented.

The Company has received approval from DCGI in Form MD-15 (Medical Device) for reducing pro-inflammatory cytokine levels in order to control the ‘cytokine storm’ and benefit COVID-19 patients who are in a critical condition.

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said: “As a science-led organization, Biocon’s endeavour is to provide innovative solutions to patients to address their unmet needs. CytoSorb is an in-licensed unique device that reduces cytokine storm in critically ill patients and was introduced by Biocon in India in 2013.

Since then many patients undergoing organ transplant and sepsis treatment have benefitted from it.  DCGI approval for emergency use of CytoSorb for critical COVID-19 patients is an important example of how industry and regulators are working in tandem to urgently provide physicians and patients with new treatment options in the fight against COVID-19. CytoSorb will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus.”

With more than 80,000* documented active coronavirus infections and over 4,000* deaths, India needs new therapies to reduce the severity of this disease.

CytoSorb is plug-and-play compatible with the most commonly used blood purification machines or pumps in the ICU used to treat COVID-19 patients, including hemoperfusion, hemodialysis, continuous renal replacement therapy (CRRT), and extracorporeal membrane oxygenation (ECMO) machines.

In April, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of CytoSorb for use in patients with COVID-19 infection.

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