Regeneron gets FDA green light on first treatment for life-threatening immune disease

Regeneron Pharmaceuticals Inc.
REGN,
+1.97%
said Friday that the U.S. Food and Drug Administration has approved its treatment for CHAPLE disease, a rare and life-threatening hereditary immune disease. The treatment, Veopoz, is the first to be approved for the condition, which can cause the body to attack normal cells and damage blood and lymph vessels in the upper digestive tract. The monoclonal antibody is approved for adults and children one year of age and older with CHAPLE disease, Regeneron said in a release. The approval of Veopoz also resolves the pre-approval inspection issues related to the regulatory submission for a higher-dose formulation of macular degeneration treatment Eylea jointly developed by Regeneron and Bayer AG
BAYRY,
-1.36%,
Regeneron said. The FDA in late June rejected the application due to an ongoing review of inspection findings at a third-party filler. Regeneron shares gained 1.2% Friday and are up 11.6% in the year to date, while the S&P 500
SPX,
-0.01%
has gained 13.8%.