Biogen’s IM Plegridy gets EU approval

pharmafile | January 6, 2021 | News story | Research and Development Biogen, multiple sclerosis 

The European Commission has approved Biogen’s Plegridy (peginterferon beta-1a), a new intramuscular (IM) injection for the treatment of relapsing-remitting multiple sclerosis (MS).

There are approximately 2.5 million people living with MS globally, with some European countries demonstrating the highest prevalence of the disease in the world.

The IM injection option is an addition to Biogen’s existing MS portfolio, which includes a subcutaneous (SC) injection of Plegridy, and also expands the range of available treatments for people living with MS.

Marketing authorisation from the EU is supported by data evaluating the bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. This data showed that participants receiving Plegridy through IM administration experienced fewer injection site reactions compared to participants receiving SC administration.

In addition, the overall safety profiles of both options were similar, and the frequency of injection site reactions and adverse events were comparable in participants who were dosed with IM followed by SC, and those given SC followed by IM.

Maha Radhakrishnan, Chief Medical Officer at Biogen, said: “The availability of a new intramuscular route of administration offers individuals living with relapsing MS an additional choice of a platform therapy, combining the safety and efficacy of Plegridy, with the potential to significantly reduce injection site reactions.

“As leaders in MS with our broad portfolio of therapies, we are focused on advancing the science to address the needs of patients by providing more treatment choices.”

Darcy Jimenez

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