FDA nod for Veopoz, first treatment for CHAPLE disease

The US Food and Drug Administration (FDA) on Friday approved Veopoz (pozelimab-bbfg) injection, a complement inhibitor, for the treatment of adult and pediatric patients aged one year and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease.

Developed by US biotech Regeneron Pharmaceuticals (Nasdaq: REGN), Veopoz is the first FDA-approved treatment for CHAPLE disease. An initial dose of Veopoz is administered intravenously, followed by weekly injections given subcutaneously (below the skin) by a health care provider.

With the approval of Veopoz, the pre-approval inspection issues that impacted the aflibercept 8mg BLA have been addressed. The FDA action on the Eylea (aflibercept) 8mg BLA is expected in the next few weeks, said Regeneron, whose shares edged up 2.9% to $818.48 on the news.