Biogen Inc. (BIIB) said Monday that the U.S. Food and Drug Administration has approved a new intramuscular (IM) injection route of administration for PLEGRIDY (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis or MS.
Biogen noted that the FDA approval expands the company's portfolio of MS treatments, which also includes the subcutaneous (SC) administration of PLEGRIDY, and follows the European Commission's marketing authorization for the IM administration in December 2020.
The new IM administration offers people living with relapsing MS the efficacy and safety of PLEGRIDY with the potential for significantly reduced injection site reactions.
MS is an autoimmune disorder that affects more than 2.3 million people worldwide.
The FDA's approval of the IM administration for PLEGRIDY is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers.
According to Biogen, bioequivalence between the two dosing regimens was confirmed and data show that participants receiving PLEGRIDY through IM administration experienced fewer injection site reactions in comparison to participants receiving SC administration (14.4 percent versus 32.1 percent).
The overall safety profiles were generally similar and there were no new safety signals observed.
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