US FDA approves Biogen’s MS drug

Biogen’s multiple sclerosis drug “Plegridy” has been approved by the US regulator


The drug has already been approved by EU

The US food and Drug Administration (USFDA) has approved Biogen's multiple sclerosis (MS) drug, Plegridy (peginterferon beta-1a). The drug is for relapsing forms of MS, taken once every two weeks. The treatment, which has got the thumbs-up based on data from a 1,500-patient study, can be administered subcutaneously with a ready-to-use autoinjector or a prefilled syringe.

Biogen quoted Mr Peter Wade, Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research, as having said, "It is a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every two-week dosing schedule administered by an innovative delivery system". He added that as a treating neurologist, "I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness".

Though, the multiple sclerosis drug market has oral treatments, including Biogen's own Tecfidera (dimethyl fumarate), Plegridy is still expected to be a successful product thanks to its offering less frequent injections and it should also be less painful than the company's older blockbuster Avonex (interferon beta-1a) which is given intramuscularly.

The European Commission approved the therapy last month.



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