Aug. 18 Quick Takes: FDA approvals for Regeneron, Neurocrine  

FDA approved Veopoz pozelimab-bbfg from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat CHAPLE disease, an ultra-rare complement-mediated protein-losing enteropathy disorder that leads to gastrointestinal and cardiovascular effects. The drug is the first to be approved for the disease, which results from CD55 mutations and affects fewer than 10 known patients in the U.S. Pozelimab is a mAb targeting C5; its PDUFA date was Aug. 20. 

The agency also approved an 8 mg formulation of Regeneron’s blockbuster VEGF inhibitor Eylea aflibercept, which showed non-inferior efficacy at dosing intervals of up to 16 weeks. The success of the formulation will depend on physician willingness to switch patients over to it in an increasingly competitive market. Phase III data last fall added $12 billion to the company’s market cap. ...