Regeneron Pharmaceuticals Inc.’s (REGN) Arcalyst as a proposed treatment for gout was unanimously rejected by a federal advisory panel on Tuesday.
The panel voted unanimously 11-0 stating Regeneron’s clinical trials were too short to prove the treatment was safe, or that it would help patients over time. The treatment is meant to be taken for 16 weeks along with a combination of other drugs.
Gout is a painful condition that affects roughly 5 million to 6 million Americans occuring when uric acid, a bodily waste product, is deposited in the joints and soft tissue. This causes inflammation, pain, redness, tenderness and a feeling of warmth in joints, much like arthritis. Gout often occurs in the joint at the base of the big toe and can make it difficult to walk.
Regneron’s injectable drug Arcalyst, also known by its generic name rilonacept, is an injection that blocks a protein called interleukin-1, which is secreted by infection-fighting cells in the body. Too much interleukin-1 can be harmful and is linked with several inflammatory diseases, including gout.
Arcalyst has already been cleared for sale to treat a rare genetic autoinflammatory disease by the FDA in February 2008. The proposed use of the medication as a treatment for gout is meant to help patients on other gout treatments that are known to cause painful flares of joint pain while the uric acid in the body is being lowered.
The FDA raised concerns in report in May that the benefit of Regeneron’s Arcalyst may be too small to justify the possible 1 in 244 risk of developing cancer, linking the drug to six cases of malignancies including prostate and breast cancers.
The panel advises that more tests be considered before the FDA approve the drug.
The FDA has until July 30th to decide on the whether or not to approve the proposed treatment by Regeneron.