FDA approves new IM administration route for Biogen’s MS drug Plegridy
pharmafile | February 2, 2021 | News story | Manufacturing and Production | Biogen, MS
The FDA has approved a new intramuscular (IM) injection route of administration for Biogen’s Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS).
The new IM administration offers people living with relapsing MS the opportunity to receive Plegridy with the potential for significantly reduced injection site reactions.
This new approval expands Biogen’s portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy, and follows the European Commission’s marketing authorisation for the IM administration in December.
The FDA’s approval of IM administration for the drug is based on data evaluating bioequivalence and adverse reactions associated with IM administration, compared to SC administration in healthy volunteers. Bioequivalence between the two dosing regimens was confirmed and data show that participants receiving the drug through IM administration experienced fewer injection site reactions in comparison to participants receiving SC administration. The overall safety profiles were generally similar and there were no new safety signals observed.
Plegridy is the only approved pegylated interferon for MS with a proven ability to delay the progression of MS disability and reduce relapses. The treatment was first 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. It is available in more than 60 countries.
Dr Maha Radhakrishnan, Chief Medical Officer at Biogen, said: “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.
“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.”
Darcy Jimenez
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