Biogen and partner Alkermes could get an FDA verdict on their new oral multiple sclerosis therapy BIIB098 by the end of the year after the agency formally started its review process.
BIIB098 (diroximel fumarate) was actually submitted for approval in the US towards the end of 2018 but appears to have been caught up in the US government shutdown last month, delaying the start of the agency’s review.
The new drug is designed to improve on the safety profile of Biogen’s established MS blockbuster Tecfidera (dimethyl fumarate), particularly with regard to its gastrointestinal tolerability. If approved, it will be sold under the proposed Vumerity brand name.
Tecfidera is a massively important product for Biogen with sales of almost $4.3bn last year, $3.3bn of which came from the US, making it far and away the company’s top-selling drug.
It’s under threat from a patent challenge from generic drugmaker Mylan, however, which if successful could carve years off Biogen’s marketing exclusivity for the drug in the US from 2028 to 2020. Meanwhile, a patent opposition lawsuit is also ongoing in Europe.
Biogen is hoping to be able to defend its MS franchise with the launch of Vumerity , even as it tries to reduce its reliance on Tecfidera by building other new products. That includes spinal muscular atrophy therapy Spinraza (nusinersen), which made $1.7bn in sales last year but could face stiff competition from Novartis/AveXis’ one-off gene therapy Zorgensma.
The US filing for Vumerity is a truncated package based on the EVOLVE-MS-1 study which showed it was bioequivalent to Tecfidera, along with pharmacokinetic bridging studies comparing the two drugs.
Biogen is also enrolling patients a head-to-head tolerability study versus Tecfidera called EVOLVE-MS-2, with data due in mid-2019, with analysts suggesting strong results will be critical if the company is to build usage of the drug before generics reach the market.
Some also say that the side effects with Tecfidera are fairly manageable and can recede with time, although a recent ‘real-world’ study conducted in Sweden found that a majority (57%) of Tecfidera patients at one clinic stopped using the drug and switched to an alternative within two years.
Alkermes is entitled to a mid-teen royalty on worldwide sales of BIIB098 under the terms of its 2017 agreement with Biogen.