Biogen Inc announced that the U.S. Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for PLEGRIDY® (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS). The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of PLEGRIDY with the potential for significantly reduced injection site reactions. This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of PLEGRIDY, and follows the European Commission’s marketing authorization for the IM administration in December 2020.
“At Biogen, we are committed to continued innovation to give people with MS more choices and more options to meet their individual preferences and needs,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “PLEGRIDY is a proven, effective therapy for relapsing MS, and this approval gives new and current MS patients a different delivery method that has the potential to significantly reduce injection site reactions.”
MS is an autoimmune disorder that affects more than 2.3 million people worldwide. Access to and availability of treatment options have become increasingly important in the current COVID-19 environment. The addition of the IM administration of PLEGRIDY to Biogen’s MS portfolio offers another important option at a time when MS patients are being encouraged to discuss their MS treatment and considerations around COVID-19 vaccination with their physicians.
The FDA’s approval of the IM administration for PLEGRIDY is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. Bioequivalence between the two dosing regimens was confirmed and data show that participants receiving PLEGRIDY through IM administration experienced fewer injection site reactions in comparison to participants receiving SC administration (14.4 percent vs. 32.1 percent). The overall safety profiles were generally similar and there were no new safety signals observed.
PLEGRIDY is the only approved pegylated interferon for MS with a proven ability to delay the progression of MS disability and reduce relapses. PLEGRIDY was first approved by the FDA in 2014 and is proven to significantly reduce MS relapses, disability progression and brain lesions with a well-understood safety and tolerability profile. It is available in more than 60 countries.
About PLEGRIDY® (peginterferon beta-1a)
PLEGRIDY is a pegylated interferon dosed once every two weeks for relapsing forms of multiple sclerosis (MS) in adults, the most common form of MS. PLEGRIDY is currently approved in over 60 countries including the U.S., Canada, Australia and Switzerland and across the European Union. Over 61,000 people worldwide have been treated with PLEGRIDY, with over 120,000 patient-years of experience, based on prescription data.4 Biogen continues to work toward making PLEGRIDY available in additional countries across the globe.
The efficacy and safety of PLEGRIDY are supported by one of the largest pivotal studies with interferons conducted in people living with relapsing-remitting MS. In clinical studies, PLEGRIDY has been proven to significantly reduce the rate of MS relapses, slow the progression of disability and reduce the number of MS brain lesions while demonstrating a well-characterized safety profile for patients with relapsing forms of MS. Side effects reported include liver problems, including liver failure and increases in liver enzymes; depression or suicidal thoughts; serious allergic reactions; injection site reactions, cardiac problems, including congestive heart failure; blood problems, such as decreases in white blood cell or platelet counts; autoimmune disorders; and seizures. In clinical trials, the most common adverse events associated with PLEGRIDY were injection site reactions and flu-like symptoms. A list of adverse events can be found in the full PLEGRIDY product labeling for each country where it is approved. PLEGRIDY can be considered for use in relapsing MS patients throughout the full course of pregnancy and during breast-feeding, if clinically needed.
