Bayer Gets CHMP Backing for Higher-Dose Eylea in Two Major Retinal Eye Diseases

By Colin Kellaher

Bayer on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of a high-dose formulation of the blockbuster eye drug Eylea in two major retinal eye diseases.

The German drugs-to-crops giant said the positive opinion covers 8-milligram doses of Eylea at extended treatment intervals of up to every four months after three initial monthly doses in wet age-related macular degeneration and diabetic macular edema.

Eylea, which Bayer is developing with Tarrytown, N.Y., biotechnology company Regeneron Pharmaceuticals, is currently approved in Europe in a 2-milligram dose every eight weeks.

The European Commission, which generally follows the CHMP's advice, is expected to make a decision in the coming months, Bayer said.

Regeneron maintains exclusive rights to Eylea in the U.S., while Bayer has licensed the exclusive marketing rights outside the U.S., where the companies equally split profits from sales of the drug.

The U.S. Food and Drug Administration approved the high-dose version of Eylea in August.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

November 10, 2023 09:45 ET (14:45 GMT)

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