Michel Vounatsos, Biogen CEO (Biogen via YouTube)

Bio­gen dodges a bul­let in its con­tro­ver­sial quest to gain an ap­proval for their ex­per­i­men­tal Alzheimer’s drug ad­u­canum­ab

David Knop­man, a pro­fes­sor of neu­rol­o­gy at the Mayo Clin­ic and a long­time ex­pert on treat­ing Alzheimer’s, was re­cused from his reg­u­lar pan­el seat on the up­com­ing re­view of Bio­gen’s Alzheimer’s drug ad­u­canum­ab by out­side ex­perts at the FDA. Reg­u­la­tors cit­ed his role as a site in­ves­ti­ga­tor for one of the two late-stage stud­ies on ad­u­canum­ab.

But his ex­pe­ri­ence in the tri­al didn’t per­suade Knop­man to sup­port Bio­gen. In­stead, he con­clud­ed that the drug won’t re­al­ly help any­one, will hurt some and def­i­nite­ly will cost “enor­mous re­sources” if ap­proved. Which Knop­man — whose pro­fes­sion­al cre­den­tials in­clude a run as chair of the Med­ical and Sci­en­tif­ic Ad­vi­so­ry Coun­cil at the Alzheimer’s As­so­ci­a­tion — is com­plete­ly op­posed to.

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