Catching up on a slew of FDA approvals in recent weeks….. whew!
The FDA recently approved a new therapy, Veopoz (pozelimab-bbfg) from Regeneron, for the treatment of adult and pediatric patients 1 year of age and older with Chaple disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is the first and only treatment indicated specifically for Chaple. Administration is by intravenous or subcutaneous injection.
Chaple is an ultra-rare and life-threatening hereditary immune disease driven by an overactivation of the complement system. In healthy individuals, the complement system is a mechanism for destroying microbes. However, those living with Chaple are unable to regulate complement activity due to mutations in their CD55 gene. Without proper CD55 regulation, the complement system may attack normal cells, causing damage to blood and lymph vessels along the upper digestive tract and leading to the loss of circulating proteins.
There are fewer than 10 patients with Chaple disease diagnosed in the U.S.
Regeneron confirmed that the cost of Veopoz will be $34,600 per vial.
Veopoz will launch through specialty distribution.
CLICK HERE to access prescribing information
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VEOPOZ (POZELIMAB-BBFG) RECEIVES FDA APPROVAL AS THE FIRST TREATMENT FOR CHILDREN AND ADULTS WITH CHAPLE DISEASE
CHAPLE is an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms
Approval represents 10th FDA-approved medicine invented by Regeneron
With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg biologics license application (BLA) have been addressed
FDA action on the aflibercept 8 mg BLA is expected in the next few weeks
TARRYTOWN, N.Y., Aug. 18, 2023 — Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved Veopoz (pozelimab-bbfg) for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is the first and only treatment indicated specifically for CHAPLE. With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg BLA have been addressed. FDA action on the aflibercept 8 mg BLA is expected in the next few weeks.
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