The FDA has expanded the label of Regeneron’s blockbuster eye therapy Eylea (aflibercept), allowing the administration of a higher 8-mg dose at up to 16-week intervals, the company announced Friday.
Regeneron and partner Bayer are betting on longer intervals between injections through the higher dose to win over patients.
Citing issues with a third-party contractor, the FDA rejected Regeneron’s regulatory application for a higher-dose regimen of Eylea, the company’s blockbuster eye injection treatment.
The FDA will close the month of June with four target action dates, including one for an investigational gene therapy for a rare disease and another for an already top-selling eye disease treatment.
The company said it was discussing with major watchdogs across the world whether the trial results are substantial enough to support a regulatory review or whether that will require the results of another ongoing trial.
The U.S. Supreme Court unanimously ruled Amgen’s cholesterol drug Repatha patents invalid, ending a protracted legal battle with competitors Sanofi and Regeneron.
As competition eats away at profits for the wet age-related macular degeneration drug, Regeneron is diversifying its portfolio and pumping more money into research and development.
Regeneron Pharmaceuticals Inc.’s first-quarter sales of blockbuster eye drug Eylea came in below Wall Street targets on Thursday as competition heated up, dragging the company’s shares more than 5% lower in early trade.
Switzerland’s Roche said first-quarter sales dropped 7% on falling demand for its COVID-19 therapies and tests, less steep than analysts had expected thanks to strong revenue growth from a new eye drug.
The U.S. Supreme Court is set to hear a bid by Amgen to revive patents on its cholesterol-lowering drug Repatha in a legal effort that rival Sanofi SA called a “blatant attempt” to squeeze competitors out of the market.