Regeneron Wins FDA Approval for Macular-Degeneration Drug

Austin, TX 11/21/11 (StreetBeat) --The folks at Regeneron Pharmaceuticals (Nasdaq: REGN) are going to have a happy weekend right before they settle down for Thanksgiving.

Tarrytown, N.Y.-based Regeneron said yesterday it has gotten clearance from the FDA to start selling afilbercept (Eylea) as a new treatment for the "wet" form of age-related macular degeneration. The drug, also known scientifically as VEGF Trap-Eye to signify its intended biological target, is designed to stop the formation of abnormal blood vessels that can often cloud the vision and ultimately lead to blindness in elderly people.

The regulatory approval puts Regeneron in position to compete with products that have transformed the treatment of macular degeneration over the past five years -- Genentech's ranibizumab (Lucentis) and bevacizumab (Avastin). The new Regeneron drug is given as a once-monthly injection in the first three months, and then a lower dose is given every two months. Regeneron said it will charge about $16,000 a year for the new product, compared with $29,000 for its direct rival, Genentech's Lucentis. The other Genentech drug, Avastin, however, is much cheaper -- although its use is more controversial because it was developed as a cancer drug. Avastin isn't approved by the FDA as a macular-degeneration treatment, but doctors prescribe it anyway because it has been found to be effective in low doses, which cost less.

"The approval of Eylea offers a much-needed new treatment option for patients with wet AMD," said Jeffrey Heier, an assistant professor of ophthalmology at Tufts School of Medicine, in a Regeneron statement. "Eylea offers the potential of achieving the efficacy we've come to expect from current anti-VEGF agents, but with less frequent injections and no monitoring requirements. This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers."

Any new treatment for age-related macular degeneration is tapping into a potentially big pool of patients, as the baby boomers get older. More than 1.7 million people in the U.S. are thought to have the disease, and incidence is continuing to climb.

Regeneron's application to the FDA was based on clinical trials of 2,412 patients who were randomly assigned to get the new drug or the standard product, Genentech's Lucentis. The studies showed the Regeneron drug was as effective as the standard treatment at improving visual clarity after one year. The side effects included eye pain, blood at the injection site, clouding of the eye lens, and an increase in eye pressure, according to a statement from the FDA.

"Eylea is an important new treatment option for adults with wet AMD," said Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, in a statement.

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