FDA will con­sult out­side ad­vi­sors on whether Bio­gen’s ALS drug can be ap­proved on a bio­mark­er

The FDA will ask a pan­el of out­side ex­perts if Bio­gen’s ALS drug should be ap­proved on the ba­sis of a new neu­rode­gen­er­a­tion dis­ease bio­mark­er.

US reg­u­la­tors plan to hold an ad­vi­so­ry com­mit­tee hear­ing on March 22 dis­cussing the mer­its of Bio­gen’s ap­pli­ca­tion for its ex­per­i­men­tal ALS drug tofersen, ac­cord­ing to a no­tice post­ed Mon­day in the fed­er­al reg­is­ter. It’s the sec­ond time the com­pa­ny will try to win an ap­proval us­ing a fresh bio­mark­er af­ter the Alzheimer’s drug Aduhelm as the FDA’s neu­ro de­part­ment con­tin­ues its shift to­ward pa­tient ac­ces­si­bil­i­ty.

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