Regeneron grabs back-to-back FDA wins
21 Aug 2023
Drug ApprovalImmunotherapy
Regeneron kicked off the weekend on a good note, sharing the approval of its ultra-rare hereditary disease drug, Veopoz, and the approval of a higher-dose formulation of its macular degeneration blockbuster Eylea.
Veopoz, a mAb designed to target complement factor C5, was approved for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathyCD55-deficient protein-losing enteropathy — marking the first and only treatment indicated specifically for CHAPLE.
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.
Hours later, Regeneron announced the approval of Eylea HD injection 8 mg for the treatment of patients with wet age-related macular degeneration (AMD), diabetic macular edema and diabetic retinopathy.
First approved in 2011 treat patients with wet AMDAMD, Eylea, which is jointly developed with Bayer, drug became a best seller. The drug is normally given via injection into the eye in doses of 2 milligrams every eight weeks. The 8 mg dose, however, proved as effective as the lower dose version but allowed for a longer gap between injections.
But back in June, the FDA hit Regeneron with a CRL for its 8 mg dose "solely due to an ongoing review of inspection findings at a third-party filler," which was later revealed to be Catalent.
Now, with the site inspection issues resolved, the agency quickly signed on off the approval.
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