Biogen’s Tecfidera follow-on Vumerity, licensed from Alkermes, has a decent shot at US approval in multiple sclerosis. But what will really determine its importance, especially once Tecfidera faces cheap generics, is the strength of the marketing message Biogen will be able to put behind it. This is why the group ran Evolve-MS-2, a head-to-head safety trial that today read out positively: Vumerity was statistically superior to Tecfidera in terms of self-reported days of GI symptoms with IGISIS intensity scores ≥2, a composite primary endpoint (p=0.0003). The devil, however, is in the detail: secondary endpoints measured individual symptom scores, and nothing has been said about these, suggesting that none was significantly reduced. And, while Biogen highlighted flushing, diarrhoea and nausea, three of Tecfidera’s four most common adverse events, as being numerically reduced with Vumerity, Evolve-MS-2 benefited from Tecfidera’s adverse events coming in rather higher than listed on the drug’s US label. On the other hand, Vumerity showed a higher rate of adverse events in Evolve-MS-2 than in the registrational Evolve-MS-1 study. Either way, how Vumerity competes against generics in a fast-evolving multiple sclerosis market will now be down to pricing and marketing muscle.
|Selected GI adverse event incidence|
|Tecfidera (US label)||Tecfidera (Evolve-MS-2)||Vumerity (Evolve-MS-2)||Vumerity (Evolve-MS-1)||Placebo (Tecfidera label)|