Bio­gen won’t ex­plain why FDA slapped down their bid for new Tysabri for­mu­la­tion

When it sub­mit­ted a sup­ple­men­tal Bi­o­log­ic Li­cense Ap­pli­ca­tion to the FDA, Bio­gen hoped they could of­fer pa­tients with mul­ti­ple scle­ro­sis an eas­i­er way of re­ceiv­ing and ad­min­is­ter­ing their ther­a­py Tysabri. But Thurs­day, it re­ceived a CRL deny­ing the ap­proval of its fil­ing, and it isn’t of­fer­ing any ex­pla­na­tion be­hind it.

The com­pa­ny turned down a re­quest for fur­ther ex­pla­na­tion from End­points News Fri­day.

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