Bio­gen, Alk­er­mes win FDA ap­proval of Tec­fidera suc­ces­sor — but can they ac­tu­al­ly sell it?

Just a few months af­ter nail­ing Phase III da­ta demon­strat­ing the greater tol­er­a­bil­i­ty of Vumer­i­ty com­pared to the block­buster fran­chise ther­a­py it’s de­signed to re­place, Bio­gen and their part­ners at Alk­er­mes have won an FDA ap­proval to start mar­ket­ing the treat­ment for mul­ti­ple scle­ro­sis.

Like much of what Alk­er­mes is known for, the drug’s fu­ture suc­cess will hinge on an im­proved safe­ty pro­file, with few­er gas­troin­testi­nal side ef­fects for MS pa­tients. That will be the key ar­gu­ment that Bio­gen will use to woo pa­tients away from their big drug Tec­fidera ahead of gener­ic com­pe­ti­tion — a cheap­er al­ter­na­tive that pay­ers will like­ly pre­fer over the new-and-im­proved drug.

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