The U.S. Food & Drug Administration (FDA) has cited a cancer risk with a new gout drug by Regeneron Pharmaceuticals. Arcalyst has been approved for the treatment of rare, genetic, auto-inflammatory conditions.
Arcalyst received mixed reviews in just-released FDA staff documents; however, Regeneron Pharmaceuticals is seeking expanded approval of the drug, said Fierce Biotech. Arcalyst was approved in February 2008 to treat the rare genetic auto inflammatory disease Cryopyrin-Associated Periodic Syndromes, said Bloomberg Businessweek.
FDA staff questioned if Arcalyst’s risks outweigh its benefits when used for the treatment of gout flare-ups, noting that the medication provided just a “small” benefit. Also, said FDA staff, six of the patients studied developed malignancies, according to Fierce Biotech. The malignancies involved prostate and breast cancer.
Based on its data, FDA staff revealed that one in every 244 people treated with Arcalyst would develop a malignancy.
Regardless, Regeneron Pharmaceuticals is seeking approval for Arcalyst to be used in patients diagnosed with gout in the 16-week period from when they are open to gout attacks to starting treatment to lower uric acid.
“From an efficacy standpoint, it will be important to address whether 16 weeks provide for an adequate duration for flare prophylaxis during initiation of (uric acid-lowering therapy),” the FDA staff said in review documents, according to Reuters. The FDA is scheduled to convene a group of advisors tomorrow to discuss expanding Arcalyst’s treatment uses, said Businessweek.
Regeneron studied Arcalyst’s use in the treatment of gout for 16 weeks, which is the amount of time the drug maker says patients will take the drug to prevent gout flare-ups when they are the most vulnerable to gout, said Businessweek. According to the FDA, this type of short-term safety data is atypical, it wrote.
FDA staff also noted that Regeneron also studied patients able to take other treatments, such as anti-inflammatory medications and colchicines.
The agency’s deadline to approve or deny the expanded Arcalyst request is set for July 30, said Businessweek.
Other gout treatments lower uric acid levels. Uric acid, or bodily waste, when present in the body in excess levels, cause gout, which is seen as joint pain, explained the National Institutes of Health (NIH). Regeneron Pharmaceuticals hopes to receive Arcalyst approval for the prevention of gout flares in patients beginning uric-acid lowering therapies.
Regeneron’s shares dropped 1.37% to $132.08 with the FDA announcement, Expanded approval could enhance revenue for the drug maker, which generated $20 million in sales in 2011, noted Businessweek. Should Arcalyst receive expanded approval, sales may reach $209 million in 2015, with $164 million from gout use alone.