'Sig­nif­i­cant ques­tions re­main' on ap­proval of Bio­gen's new Alzheimer's drug, con­gres­sion­al com­mit­tees tell FDA

Two promi­nent House com­mit­tees are dig­ging deep­er in­to the FDA’s cozy re­la­tion­ship with Bio­gen as it re­viewed and ap­proved its new Alzheimer’s drug Aduhelm.

While the com­mit­tees were briefed by FDA on the sit­u­a­tion in mid-Ju­ly, the chairs are now telling FDA, “This in­for­ma­tion was help­ful, but sig­nif­i­cant ques­tions re­main.”

The House En­er­gy & Com­merce and Over­sight com­mit­tee chairs are now re­quest­ing in a let­ter this week to act­ing com­mis­sion­er Janet Wood­cock that FDA pro­vide very spe­cif­ic in­fo by Sept. 16. The re­quest­ed in­for­ma­tion in­cludes the body of ev­i­dence up­on which reg­u­la­tors re­lied to de­ter­mine the use of amy­loid be­ta plaque as a sur­ro­gate end­point as “rea­son­ably like­ly to pre­dict clin­i­cal ben­e­fit” for Alzheimer’s dis­ease, and what ac­tu­al­ly hap­pened be­tween the FDA and Bio­gen lead­ing up to the ap­proval.

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