The Food and Drug Administration (FDA) has approved Plegridy (peginterferon beta-1a; Biogen) for intramuscular (IM) administration for the treatment of relapsed forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary disease progressive disease in adults. Previously, the product was only approved for subcutaneous (SC) administration.
The approval for the use of IM was based on data from an open crossover study, in which the bioequivalence of single doses of 125 µg Plegridy as SC and IM injection was examined in 130 healthy volunteers. The results showed similar pharmacokinetics between the SC and IM injections. Overall, injection site reactions were reported in 14% of people who received the IM injection versus 32% of those who received the SC injection.
Commenting on the approval, Maha Radhakrishnan, Biogen’s Chief Medical Officer, said: “Plegridy is a proven and effective therapy for relapsing MS. With this approval, new and current MS patients will have a different delivery method that may significantly reduce injection site reactions. ”
In patients receiving an IM injection for the first time, Plegridy should be titrated with the Plegridy titration kit, which is designed for use with prefilled syringes. Plegridy for IM injection is supplied as a single-dose, pre-filled syringe containing 125 µg / 0.5 ml peginterferon beta-1a and packaged with a separate needle. The rubber cover of the pre-filled syringe contains natural rubber latex, which can cause allergic reactions in sensitive people.
1. Biogen Announces FDA Approval of Plegridy® (Peginterferon Beta-1a) Intramuscular Administration for Multiple Sclerosis. [press release]. Cambridge, MA; Biogen; February 1, 2021.
2. Plegridy [prescribing information]. Cambridge, MA: Biogen Inc; 2021.
This article originally appeared on MPR
Multiple Sclerosis Treatments