© Reuters. FILE PHOTO: The Regeneron Pharmaceuticals logo is seen on a building on the company’s Westchester campus in Tarrytown, New York, US, September 17, 2020. REUTERS/Brendan McDiarmid/File Photo
Posted by Khushi Mandwara
(Reuters) – U.S. health regulators on Tuesday refused to approve a higher-dose version of Regeneron (Nasdaq:) for the drug to treat a disease that causes blindness in the elderly, the company said. A setback for her efforts to defend the blockbuster remedy against a fast-growing competitor.
Shares of Regeneron closed down 8.6% at $715.9.
The FDA issued a full response letter, indicating that the agency has reviewed Regeneron’s application and has questions outstanding. The letter cited an ongoing review of screening results in third-party, higher-dose fillers.
Regeneron said it is working with the U.S. Food and Drug Administration and a third-party filler company to offer patients a higher dose as quickly as possible.
The full response letter did not identify any issues related to the drug’s clinical efficacy or safety, trial design, labeling or manufacturing of the drug substance, and no additional clinical or study data were requested.
Analysts expect the drug to be approved eventually. Truist analyst Robyn Karnauskas said the compliance issue meant a delay of about 6 months.
Eylea, which reported $9.65 billion in global sales last year, has been hurting since Roche’s rival Vabysmo treatment was approved last year for age-related macular degeneration (AMD) and diabetic macular edema.
Regeneron was seeking approval for the drug to treat wet AMD, a leading cause of blindness among the elderly, and two common eye diseases in people with diabetes.
Analysts had expected that some doctors might prefer a higher dose of Elijah over a lower-dose version of the same drug or Roche Vapismo, since it would have a longer gap between injections into the eye.
Eylea is usually given in doses of 2 milligrams every eight weeks. Two late-stage trials showed that Eylea was as effective as the lower-dose version when given at a dose of 8 milligrams over longer periods without any additional safety issues.
An estimated 1.1 million people in the United States have wet AMD, while an estimated 1.2 million have DME, according to Regeneron.
It’s also possible that Eylea will face competition from biosimilars late next year as some patents expire.
(This story has been corrected to change the source to a company from regulators, in paragraph 1)