Geoffrey Porges, SVB Leerink

Se­ries of JAK in­hibitor de­lays may sig­nal an up­com­ing FDA ad­comm

Three-month re­view de­lays from the FDA have be­come the norm in re­cent days for JAK in­hibitors, some of which are seek­ing la­bel ex­pan­sions.

But the push­back of these ac­tion dates for Ab­b­Vie’s Rin­voq, Pfiz­er’s Xel­janz and abroc­i­tinib, and Eli Lil­ly’s Olu­mi­ant may be a sign that the FDA is prepar­ing to hold an ad­vi­so­ry com­mit­tee of out­side ex­perts to re­view the risk/ben­e­fit pro­files of JAK in­hibitors for atopic der­mati­tis, ac­cord­ing to SVB Leerink an­a­lyst Ge­of­frey Porges. This wouldn’t be the first time this year that the FDA wants to re­view a se­ries of drugs be­fore an ad­comm as the agency is hold­ing such a re­view lat­er this month for can­cer drugs that have pre­vi­ous­ly won ac­cel­er­at­ed ap­provals.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA