Regulators in the USA have given the green light to another Biogen Idec multiple sclerosis drug, this time Plegridy.
The US Food and Drug Administration has approved Plegridy (peginterferon beta-1a) for relapsing forms of MS. dosed 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 Peter Wade of the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research in Hartford, Connecticut, as saying that Plegridy 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”.
While the MS market now has oral treatments, including Biogen’s own Tecfidera (dimethyl fumarate), Plegridy is still expected to be a successful product thanks to 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.
In March, the FDA extended the initial Prescription Drug User Fee Act (PDUFA) date for Plegridy by three months, saying it needed more time to review the file. The European Commission approved the therapy last month.
