June 27 Quick Takes: FDA denies Regeneron’s high-dose Eylea

Citing inspection findings at a third-party filler, FDA issued a complete response letter for an 8 mg dose of Eylea aflibercept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. The company said it will seek to resolve the issue and gain the therapy’s approval, which would extend its Eylea franchise with a formulation that confers a dosing advantage over its existing product, particularly as competing bispecific mAb Vabysmo faricimab-svoa from Roche (SIX:ROG; OTCQX:RHHBY) gains market share. Regeneron used a priority review voucher to accelerate the review. Its shares slipped 9% to $716.09 on Tuesday, representing about $7.5 billion in lost market cap.

The anti-OX40L antibody obtained by Sanofi (Euronext:SAN; NASDAQ:SNY) via its $1.1 billion acquisition of Kymab Ltd. in 2021 has met the primary endpoint in a Phase IIb study to treat atopic dermatitis. The pharma said amlitelimab significantly improved disease scores in the STREAM-AD study; it is planning Phase III development. Sanofi believes it could be a first-in-class therapy in the indication, one of several for which OX40L inhibitors are in development across the oncology and autoimmune fields...