FDA OKs New Intramuscular Administration for Multiple Sclerosis Therapy

Officials with the FDA have approved a new intramuscular (IM) injection route of administration for Biogen’s peginterferon beta-1a (Plegridy) for the treatment of relapsing forms of multiple sclerosis (MS).

Peginterferon beta-1a, a pegylated interferon, was initially 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, according to Biogen.

The FDA’s approval of the IM administration of peginterferon beta-1a is based on data evaluating the bioequivalence and adverse effects associated with IM administration compared with subcutaneous (SC) administration in healthy participants. According to the results, bioequivalence between the 2 dosing regimens was confirmed. Participants receiving peginterferon beta-1a through IM administration also experienced fewer injection site reactions compared with those who received SC administration (14.4% versus 32.1%, respectively).

“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,” Maha Radhakrishnan, MD, chief medical officer at Biogen, said in a statement. “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.”

Reference

1. Biogen Announces FDA Approval of PLEGRIDY (peginterferon beta-1a ) Intramuscular Administration for Multiple Sclerosis. News release. Biogen; February 1, 2021. Accessed February 1, 2021. https://www.globenewswire.com/news-release/2021/02/01/2167195/0/en/Biogen-Announces-FDA-Approval-of-PLEGRIDY-peginterferon-beta-1a-Intramuscular-Administration-for-Multiple-Sclerosis.html