J&J's Arthritis Candidate Sirukumab Denied FDA Approval

Johnson & Johnson (NYSE:JNJ) announced that the FDA has denied approval to its investigational rheumatoid arthritis (RA) treatment, sirukumab, an IL-6 inhibitor, for want of additional safety data.

The FDA issued a complete response letter (CRL) for J&J’s Biologics License Application (BLA) for sirukumab which was filed in September last year.

The company is looking to get sirukumab approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).

Regulatory applications are under review in EU and Japan as well. The proposed trade name for sirukumab is Plivensia.

So far this year, J&J’s share price has increased 13.8%, comparing unfavorably with a gain of 17% recorded by the industry it belongs to.

The CRL was somewhat expected as last month, FDA’s Arthritis Advisory Committee had not recommended approval of sirukumab, raising some safety concerns. The panel was concerned with the increased mortality rates for both the evaluated doses of (50 mg and 100 mg) of sirukumab.

The FDA in its CRL has asked for additional clinical data to further evaluate the safety of the candidate. J&J plans to meet with the FDA for a follow-up discussion. The CRL is expected to delay the drug’s approval, which was previously expected to happen this year.

In July this year, J&J’s partner for sirukumab, U.K. based drug giant GlaxoSmithKline plc (NYSE:GSK) , informed the termination of its collaboration with J&J.

We remind investors that Eli Lilly & Company (NYSE:LLY) and partner Incyte Corporation (NASDAQ:INCY) had also received a CRL for their experimental JAK inhibitor, baricitinib to treat RA as the FDA demanded additional data.

However, in August, the companies informed that they will re-submit the NDA for baricitinib much faster than previously expected as they will not be required to conduct an additional study. The NDA is expected to be re-submitted in January next year.

RA is a common, chronic, life-long, autoimmune disease that affects about 1.3 million people in the United States.

J&J carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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