EU authorises intramuscular administration of Biogen’s Plegridy for MS

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

Approximately 2.5 million people live with MS across the world, with some European countries demonstrating the highest prevalence of this disease in the world.

The new IM injection option complements Biogen’s existing MS portfolio, which include a subcutaneous (SC) injection of Plegridy, and also expands the range of available treatments for people living with MS.

“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,” said Maha Radhakrishnan, chief medical officer at Biogen.

“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,” she added.

The EU marketing authorisation 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, as compared to SC followed by IM.