Regeneron Announces FDA Approval for Treatment of Rare Immune Disease

Regeneron Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Veopoz, a groundbreaking treatment for CHAPLE disease. CHAPLE disease is a hereditary immune disease that poses a serious threat to individuals affected by it. Veopoz is the first treatment to be approved for this condition.

CHAPLE disease can lead to the body attacking normal cells, causing damage to blood and lymph vessels in the upper digestive tract. The newly approved monoclonal antibody treatment is suitable for both adults and children aged one and above who have been diagnosed with CHAPLE disease.

Regeneron, in a press release, expressed satisfaction with the FDA’s decision to approve Veopoz. This approval also resolves the issues encountered during the pre-approval inspection of the higher-dose formulation of macular degeneration treatment Eylea, which was jointly developed by Regeneron and Bayer AG.

Earlier this year, the FDA rejected the application due to an ongoing review of inspection findings at a third-party filler facility. However, with the approval of Veopoz, these concerns have been addressed.

In response to this positive news, Regeneron shares saw a 1.2% increase on Friday and have shown an overall growth of 11.6% year-to-date. On the other hand, the general stock market, as represented by the S&P 500, has gained 13.8% during the same period.