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J&J arthritis drug raises safety concerns at FDA

July 31, 2017

Johnson & Johnson (JNJ)’s investigational rheumatoid arthritis treatment has run into some serious criticism from a U.S. Food and Drug Administration advisory panel.

In a briefing document released this morning, the FDA panel raised concern over the safety of the RA drug sirukumab. In the review, the FDA said there was a clear imbalance in deaths and malignancies among the patients who took the drug over a 52-week period. The panel noted there have been more deaths associated with patients taking the drug than those taking placebo. The deaths were primarily related to cardiovascular issues, dubbed MACE (major adverse cardiac events) in the FDA’s briefing.

“The common causes of mortality were MACE, infection, and malignancy. The increased mortality was seen with both sirukumab doses at comparable rates. Sirukumab was associated with increased risk of serious infection, and there were reports of opportunistic infection and tuberculosis. Sirukumab treatment was associated with laboratory abnormalities including neutrophil count decrease, liver function test values increase, and increase in lipid parameters of LDL, HDL, and triglyceride,” the FDA said in its briefing document.

Additionally, the FDA said the safety issues “related to immune system suppression were similar to other products in the class,” Reuters noted in its report. However, the FDA went on to say that the trend of increased overall mortality “seems unique for the sirukumab program,” Reuters said, citing the FDA report.

The FDA report comes two days before an advisory committee is set to discuss sirukumab and recommend whether or not the FDA should approve its use for RA patients.

Sirukumab is a human anti-interleukin (IL)-6 monoclonal antibody in development for the treatment of adults with moderately to severely active rheumatoid arthritis.

The FDA’s report comes only a week after GlaxoSmithKline (GSK) announced it was withdrawing from its sirukumab partnership with J&J as that company shifts the bulk of its resources to focus on development of treatments for respiratory and HIV/infectious diseases.

In addition to the safety concerns the FDA panel raised about sirukumab, the panel noted the drug did demonstrate efficacy in its 50 mg and 100 mg doses, but were not superior to adalimumab, which is AbbVie (ABBV)’s Humira – a drug it went head-to-head against in a Phase III trial last year. J&J has proposed that the FDA approve the 50 mg dose due to its “efficacy and safety” data, the FDA said.

The RA market is getting tighter and the FDA is becoming more stringent in its drug reviews. Earlier this year, the FDA rejected baricitinib, a rheumatoid arthritis drug being jointly developed by Eli Lilly (LLY) and Incyte Corporation (INCY). As a result, the two companies said last week there will be a significant delay in refiling for regulatory approval. The FDA rejected the drug due to an “observed imbalance in thromboembolic events that occurred during the placebo-controlled period of the RA clinical program.”

If the J&J RA drug is approved, it would certainly face stiff competition from the newly dubbed Kevzara, an RA drug jointly developed by Sanofi (SNY) and Regeneron (REGN) that was approved in 2016.

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