Regeneron expects FDA decision on higher-dose Eylea this year

By Khushi Mandowara

(Reuters) -Regeneron Pharmaceuticals expects a U.S. decision on a higher-dose version of its blockbuster eye disease drug Eylea in the third quarter, much earlier than market expectations, sending its shares up 5% on Thursday.

The U.S. Food and Drug Administration declined to approve the higher-dose version in June following an inspection at third-party manufacturer Catalent.

Regeneron said it has been submitting manufacturing data required by the FDA on a rolling basis, and expects to finish the submissions by mid-August.

It expects the FDA to decide on the drug in the third quarter, compared with expectations of a review next year.

Regeneron said the higher-dose Eylea was manufactured on the same line as pozelimab, its experimental drug being reviewed to treat a rare blood disease. A decision on that drug is due by Aug. 20.

“We think approval of pozelimab would be a huge positive for (high dose) Eylea time lines,” said Wells Fargo analyst Mohit Bansal.

Analysts have said an approval of the higher-dose version of the eye drug could provide a defense against rivals such as Roche’s Vabysmo.

Regeneron and partner Bayer are betting on longer intervals between injections through the higher dose to win over patients.

U.S. sales of Eylea fell 7% to $1.50 billion in the second quarter, but came in slightly above estimates of $1.48 billion.

Meanwhile, sales of eczema drug Dupixent, recorded by partner Sanofi, surged 33% to $2.79 billion during the quarter. Sales of the treatment, which was approved in 2017, have helped mitigate the decline in sales of Eylea.

Regeneron reported an adjusted profit of $10.24 per share for the quarter, topping analysts’ estimates of $9.84, according to Refinitiv data.

(Reporting by Khushi Mandowara in Bengaluru; Editing by Sriraj Kalluvila)