Biogen Idec To Pursue Disability Label Claim For BG-12 Despite Missed Endpoint
This article was originally published in Pharmaceutical Approvals Monthly
Relapse reduction in multiple sclerosis was robust, though lower than in the first Phase III trial, but the drug missed the statistical mark on disability progression.
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Several new drugs for multiple sclerosis could launch within the next two years, but amid escalating drug costs, payors are taking a harder look at the therapeutic category. New drugs will face increasing reimbursement hurdles, as payors implement the first prior authorization and step therapy protocols and look for ways to implement further cost reductions.
MS drug spending is skyrocketing due to premium-priced new drugs and defensive price hikes across the category, making the therapeutic area a management priority for payers. Insurers are largely relying on aggressive contracting with manufacturers to manage the category, but new launches are unlikely to secure preferred formulary placement without comparative safety and efficacy data.
Novartis AG's Gilenya (fingolimod) – the first oral treatment for multiple sclerosis – is off to a modestly strong start. The drug’s sales performance since its U.S. launch in October has been respectable, if not remarkable, driven by both market expansion and patient switches.