(By R. Chandrasekaran) On May 8, Food and Drug Administration's advisory panel will meet to review on Regeneron Pharmaceuticals' (Nasdaq: REGN
) drug Arcalyst for preventing gout flares.
In last November, the company had applied for supplemental Biologics License Application (sBLA) for its drug Arcalyst injection for gout flare prevention in patients beginning with uric acid-lowering treatment.
Generally, gout flares happen in men in the age group of 40 to 60, though there are some instances where it happens for men aged in early 30s. For women, it occurs after the menopause.
It is widely believed that gout attacks are connected with wine and rich food and was generally termed as a rich man's disease. But this has been termed as wrong impression and that even healthy foods could contribute to gout flares. This impression gains ground for the simple reason that most of drinks and foods contain purines, which are grasped and turned into uric acid. Generally, these are removed from the body, but patients suffering from gout flares have reduced capability to remove it. This builds up into the system.
Currently, an estimated 8.3 million people in the U.S. seem to have been affected by gout attack. According to an estimate by Decision Resources, drug market size for acute gout will triple to $117 million, and that of the chronic gout to reach $1.83 billion by 2019.
Interestingly, a FDA staff has reportedly commented that Regeneron's Arcalyst may not necessarily offer sufficient benefit to prevent gout attack that is worth in taking side effects risk. But the benefit of the drug in small dimension was indicated.
This will throw an interesting scenario for the advisory panel to decide. There is every chance that the panel voting may be divided.
The latest FDA news seems to have hurt investors' sentiments on the stock as it is trading $2.34 or 1.75 percent lower at $131.58.