EU approves new intramuscular injection of Plegridy for multiple sclerosis.- Biogen

Biogen Inc. announced that the European Commission (EC) has approved a new intramuscular (IM) injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing-remitting multiple sclerosis (MS). The new IM administration of Plegridy provides the well-characterized efficacy and safety of the platform injectable along with the potential for reduction in injection site reactions.The EC’s approval of Plegridy for IM administration 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 Plegridy through IM administration experienced fewer injection site reactions in comparison to participants receiving SC administration (14.4 percent vs. 32.1 percent). The overall safety profiles were similar, and the frequency of injection site reactions and adverse events were comparable in participants who were dosed with IM followed by SC, compared to SC followed by IM.Subcutaneous delivery of Plegridy was approved in the EU in 2014.