BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide today announced that its BTK inhibitor BRUKINSA™ (zanubrutinib) has been approved by the Ministry of Health in Kuwait, the National Health Regulatory Authority in Bahrain and the Ministry of Public Health in Qatar for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. BeiGene is working with NewBridge Pharmaceuticals, a specialty company in the Middle East and North Africa (MENA) regions established to bridge the access gap by partnering with global pharma and biotech companies, to bring BRUKINSA to patients in Kuwait, Bahrain, Qatar, Saudi Arabia, United Arab Emirates, and other markets in the MENA region following regulatory approvals.
“Non-Hodgkin’s lymphoma is among the five most common cancers in Kuwait, Bahrain, and Qatar, with MCL in particular having a poor prognosis. Patients typically require multiple lines of therapy where the duration of response to subsequent lines of treatment is continually reduced,” said Dr. Abdul Aziz Hamadah, Head of Hematology Department, Kuwait Cancer Control Center. “BRUKINSA is a next-generation BTK inhibitor designed as a highly potent, selective, bioavailable, and irreversible inhibitor with potentially advantageous pharmacokinetic and pharmacodynamic properties.”
“BeiGene’s vision is to develop impactful medicines and reach far more patients around the world. Over the past year, BeiGene has achieved approval for BRUKINSA in five countries in the MENA region including Saudi Arabia, United Arab Emirates, Kuwait, Bahrain and Qatar,” said Mohammed Al-Kapany, Senior Director of New Markets in MENA at BeiGene. “We are proud to be on a path to bringing an important new treatment option to patients.”
Added Joe Henein, President and CEO of NewBridge Pharmaceuticals, “Continuing our productive collaboration with BeiGene in the MENA region, we look forward to introducing BRUKINSA to physicians and their patients in Kuwait, Bahrain and Qatar.”
The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering 50 countries and regions, including the United States, China, the EU, and Great Britain, Canada, Australia and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.
