Biogen recently announced that the U.S. Food and Drug Administration (FDA) has approved Plegridy (pegylated interferon β-1a), a new intramuscular (IM) injection administration route for treatment of patients with relapsing multiple sclerosis (RMS). This new IM administration route can provide good efficacy and safety, has the ability to reduce recurrence and delay the progression of disability, and has the potential to significantly reduce injection site reactions. In the European Union, Plegridy intramuscular injection administration route is in December 2020 Approved.
Multiple sclerosis (MS) is an autoimmune disease that affects more than 2.3 million people worldwide. This approval expands Biogen’s industry-leading portfolio in the treatment of multiple sclerosis, including subcutaneous (SC) injections of Plegridy, And expand the scope of treatment options for MS patients.
Plegridy is the only peginterferon approved for multiple sclerosis (MS). It has the ability to delay the progression of disability and reduce recurrence. Plegridy was first approved by the US FDA in 2014 and has been shown to significantly reduce MS Recurrence, disability progression, and brain damage, and has good safety and tolerability. Currently, Plegridy has been marketed in more than 60 countries around the world.
The U.S. FDA approval of the Plegridy IM route was based on data evaluating bioequivalence and adverse effects associated with IM administration and subcutaneous (SC) injection administration in healthy volunteers.The results confirmed that the two dosing regimens are bioequivalent, subjects given IM had fewer injection-site reactions than those given SC (14.4% vs 32.1%).The overall safety status was similar, and the injection site reactions and adverse events were similar.
Dr. Maha Radhakrishnan, Chief Medical Officer of Biogen, said: “At Biogen, we are committed to continuous innovation to provide MS patients with more choices to meet their personal preferences and needs. Plegridy is a proven treatment for relapsing multiple sclerosis. This approval will provide a different method of administration for patients with multiple sclerosis, which has the potential to significantly reduce injection site reactions.”
Reference
Biogen Announces FDA approval of PLEGRIDY (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis