Regeneron Pharmaceuticals, Inc., has again been unsuccessful in obtaining U.S. government approval for expanded use of its Arcalyst drug for the prevention of gout. In May, a Food and Drug (FDA) administration advisory panel unanimously rejected the same drug as a gout treatment on grounds that a clinical trial over a-16 week period was too short to establish patient safety or that it would help gout patients over time.
U.S. government regulators in the FDA have asked for more clinical data from Regeneron “including chemistry, manufacturing and controls information related to a proposed new dosage form for the injectable drug” according to Reuters. Regeneron indicated that that it was reviewing the FDA’s request.
Aracalyst (generic name rilonacept) is apparently an acceptable drug therapy for “a group of rare genetic auto-inflammatory diseases” and was cleared by the FDA for that purpose in 2008.
Regneron’s Arcalyst is said to block 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.
Gout is a painful condition that affects roughly five to six million Americans that occurs when uric acid, a bodily waste product, is deposited in the joints and soft tissue. This condition 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.
Regeneron Pharmaceuticals recently obtained approval for its macular degeneration-treating drug Eylea.