FDA Rejects J&J Arthritis Drug

Sep 25, 2017

Johnson & Johnson subsidiary, Janssen Biotech, announced that its biologics license application for experimental arthritis therapy, sirukumab, was rejected by the FDA.

FDA's complete response letter said that additional clinical data are needed to further evaluate the safety of the new drug candidate.

The rejection should not come as a surprise to J&J, after an FDA panel voted 12-1 against the approval of the drug in August, citing safety concerns. A week prior to the panel rejection, GSK announced that it would end its collaboration with J&J on the experimental drug.

Sirukumab is currently still under review by health authorities in Europe and Japan as a subcutaneous therapy for the treatment of adult patients with moderately to severely active RA.

Read the press release



Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.


No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments