FDA push­es back de­ci­sions on Ab­b­Vie's Rin­voq sNDAs to fur­ther re­view a failed Pfiz­er tri­al

Safe­ty ques­tions re­lat­ed to the lu­cra­tive class of med­i­cines known as JAK in­hibitors are con­tin­u­ing to slow the push to ex­pand their la­bels.

Ab­b­Vie on Fri­day an­nounced that the FDA said it will not meet its ac­tion dates for the sNDAs for its JAK in­hibitor Rin­voq. The com­pa­ny is seek­ing to use the drug as a treat­ment of adults with ac­tive pso­ri­at­ic arthri­tis and adults with ac­tive anky­los­ing spondyli­tis and did not say how long the de­lay will be.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER