Days after FDA rejection, Regeneron wins label expansion for Eylea

Regeneron's Eylea generated nearly $2 billion in U.S. sales in the first six months of 2018. (Regeneron)

Regeneron started the week with a piece of bad news that the FDA rejected Eylea in a new 12-week dosing formulation. But in an extremely quick reversal by the regulator, Regeneron on Friday secured the approval.

Eylea picked up an FDA approval in wet age-related macular degeneration in a 12-week dosing formulation, Regeneron announced. The drug is additionally approved in four- and eight-week dosing. The new approval comes after the company suffered a complete response letter for its application on Monday. 

When announcing the rejection, Regeneron said it expected discussions around a final FDA action to take about two months. Now, it’s secured an FDA reversal in four days. 

In a statement, Regeneron Chief Scientific Officer George Yancopoulos said the label addition “will help physicians make the most informed choices in treating patients suffering from wet age-related macular degeneration."  

The approval will help Regeneron position its med against a forthcoming competitor from Novartis. That drugmaker plans an FDA application late this year for RTH258, which it hopes can also win a 12-week label. If that med secures approval, the rival Swiss drug giants would be in a head-to-head showdown in the class.

Friday's news should provide a boost for Regeneron as Eylea continues to carry the torch sales-wise for the company. For the first six months of the year, U.S. sales for the drug approached $2 billion. Meanwhile, Regeneron is marketing and advancing a group of monoclonal antibodies under a collaboration with Sanofi. A recent launch under the partnership is Dupixent, an atopic dermatitis treatment that’s jumped out to a quick start commercially after its March 2017 rollout.

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