FDA approves intramuscular formulation of Plegridy for relapsing forms of MS

The FDA has approved an intramuscular injection formulation of peginterferon beta-1a for use in patients with relapsing forms of MS, according to a press release from Biogen, the drug’s manufacturer.

The new formulation offers the potential of “significantly reduced” injection site reactions, the press release noted.

The FDA based the approval of the intramuscular injection formulation of Plegridy (peginterferon beta-1a, Biogen) on data that examined bioequivalence and adverse reactions due to this route of administration compared with subcutaneous administration in healthy volunteers. The data confirmed bioequivalence between the two; participants treated with peginterferon beta-1a via intramuscular injection experienced fewer injection site reactions compared with individuals receiving the subcutaneous dose (14.4% vs. 32.1%). The data showed “generally similar” safety profiles and no new safety signals.

The FDA first approved peginterferon beta-1a in 2014. The drug is “the only approved pegylated interferon for MS with [the] ability to delay the progression of MS disability and reduce relapses,” according to the press release.

“[Peginterferon beta-1a] is a proven, effective therapy for relapsing MS,” Maha Radhakrishnan, MD, chief medical officer at Biogen, said in the release. “... This approval gives new and current MS patients a different delivery method that has the potential to significantly reduce injection site reactions.”

Reference:

Biogen. Biogen announces FDA approval of Plegridy (peginterferon beta-1A) intramuscular administration for multiple sclerosis. Available at: https://investors.biogen.com/news-releases/news-release-details/biogen-announces-fda-approval-plegridyr-peginterferon-beta-1a. Accessed Feb. 1, 2021.