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Regeneron's eye disorder drug Eylea wins US approval

FDA licences Lucentis competitor to treat patients with wet age-related macular degeneration

Regeneron Pharmaceuticals' Eylea (aflibercept) has been approved in the US to treat one of the leading causes of blindness.

The Food and Drug Administration (FDA) licensed the drug to treat patients with wet (neovascular) age-related macular degeneration (AMD) – a growth of abnormal blood vessels in the eye.

Current treatments for the disorder include Lucentis (ranibizumab injection), which is marketed in the US by Genentech/Roche and elsewhere by Novartis. By the end of September 2011, Lucentis had sales of $1.5bn for Novartis during the year and around $1.2bn for Genentech/Roche.

In two head-to-head trials of the two drugs Eylea was demonstrated to be as effective as Lucentis in maintaining or improving the quality of someone's sight.

The primary endpoint in each study was a patient's clearness of vision after one year of treatment.

Eylea's case over Lucentis is its less frequent dosing. The trials showed that an Eylea dose every eight weeks, following three initial monthly injections, gave similar results as a consistent four week dose of Lucentis.

Dr Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said: “Eylea is an important new treatment option for adults with wet AMD. It is a potentially blinding disease and the availability of new treatment options is important.”

Wet AMD can lead to leaked fluid into the macula, a part of the retina, causing the macula to thicken leading to vision loss.

The approval was granted under the FDA's priority review, which allows fast-tracked approval of a drug that offers a major advance in treatment, or provides a treatment in an area where no adequate therapy currently exists.

Regeneron is collaborating with Bayer HealthCare on the development of Eylea outside the US. An application for marketing authorisation to the European Medicines Agency for wet AMD was made in June 2011.

23rd November 2011

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