Fresh from getting the green light for its blindness drug Eylea, Regeneron Pharmaceuticals says US regulators are considering its Arcalyst drug as a treatment for gout.
The US Food and Drug Administration has accepted for review the company's supplemental Biologics License Application for Arcalyst (rilonacept) injection for subcutaneous use for the prevention of gout flares in patients initiating uric acid-lowering therapy. A standard review is ten months from submission, so the action date is July 30 next year.
Arcalyst is already sold for cryopyrin-associated periodic syndromes (CAPS), a rare genetic autoinflammatory disease. It is not a big earner, and third quarter sales reached just $5.5 million (+12.2%), but getting approval for the gout indication would boost that figure.
News of the review comes days after the FDA approved Eylea (aflibercept) also known as VEGF Trap-Eye, for the treatment of patients with wet age-related macular degeneration. Analysts believe the company has a blockbuster on its hands and investors seem to think so too - Regeneron stock is up about 70% for the year to date.