Regeneron said it had won U.S. Food and Drug Administration (USFDA) approval for less-frequent applications of its Eylea anti-blindness treatment, which may come under pressure from a rival product made by Novartis
This marks a turnaround from earlier in the week when the U.S. regulator had issued a complete response letter which indicated it was not yet satisfied with the information provided by Regeneron. Regeneron did not give any reason for the change in its statement on Friday.
The go-ahead was based on second-year data from the so-called VIEW 1 and 2 trials, showing patients with wet age-related macular degeneration (wet AMD) can be treated with a modified 12-week dosing schedule.
Eylea is currently approved in wet AMD for dosing intervals of every four or eight weeks after three initial monthly doses.
Regeneron’s Partner Bayer, for its part, earlier this month won approval in Europe for Eylea also to be injected less frequently.
This could be a relief for patients of wet AMD, the leading cause of blindness in the elderly, as the drug is given as injections into the eye.
In November, Novartis’s rival eye drug brolucizumab, also known as RTH258, was shown to lead to less disease activity than Eylea. According to previous study results, brolucizumab could be injected less frequently than Eylea.
Regeneron sells the drug in the U.S. and Bayer in the rest of the world. Wet AMD leads to abnormal blood vessels that leak fluid into the eye and cause blindness.
Regeneron reported 2017 U.S. revenue of $3.7 billion from the drug. With sales of 1.88 billion euros ($2.14 billion) in 2017 for Bayer, Eylea is the German group’s second-biggest selling drug after stroke prevention pill Xarelto. ($1 = 0.8780 euros)
(Reporting by Ludwig Burger. Editing by Jane Merriman)