(Reuters) – Regeneron Pharmaceuticals Inc said on Thursday the U.S. Food and Drug Administration declined to approve a pre-filled syringe version of its blockbuster eye drug Eylea, and has sought additional information regarding its manufacturing and supply processes.
The drugmaker said the rejection does not affect its earlier expectation of launching the product in 2019. It plans to resubmit its application early next year.
Regeneron told Reuters the regulator has also asked for the completion of a small study, involving about 30 patients, to demonstrate doctors are able to administer the product.
Eylea has made Regeneron a dominant player in the eye-disease space and brought in sales of $3.70 billion in the United States last year.
But with Swiss drugmaker Roche AG’s prefilled syringe rival treatment threatening market share, Regeneron has thrown marketing heft behind Eylea and pushed for its approval in additional indications.
Regeneron also said Eylea met the main goal in a late-stage trial testing it in patients with moderately severe and severe diabetic retinopathy, an eye disease that is the leading cause of vision impairment and blindness among working-age adults.
Data from the one-year trial showed that without treatment, over a third of patients developed a vision-threatening complication or diabetic macular edema (DME).
“Eylea was able to reduce these complications by 68 percent to 85 percent even with every four-month dosing, and moreover was able to reverse the anatomic severity of the disease,” Chief Scientific Officer George Yancopoulos said.
Eylea is currently approved to treat the about 1.5 million adults living with DME in the United States.
The new data will contribute to the company’s application that seeks to expand use of the drug to people with diabetic retinopathy at risk of developing DME, expected to receive an FDA decision by May.
Reporting by Tamara Mathias in Bengaluru; Editing by Shailesh Kuber