Amryt Pharma Says FDA Extends Oleogel-S10 New Drug Application Review by Three Months

By Ian Walker

Amryt Pharma PLC said Tuesday that the U.S. Food and Drug Administration had extended the company's new drug application review for Oleogel-S10 by three months so it can evaluate additional data that has been submitted by the company.

The biopharmaceutical company said the Prescription Drug User Fee Act goal date is now Feb. 28.

"This is a standard review extension period to allow the FDA additional time to review information already submitted by Amryt," the company said. It added that the FDA has also issued a new information request over existing study data so that it can continue evaluating the application.

The European Medicines Agency review is also continuing and its Committee for Medicinal Products for Human Use's opinion is now expected in January, the company said.

Oleogel-S10 is a treatment for epidermolysis bullosa, a rare genetic skin disorder.

Amryt said its guidance isn't affected by the extended timeline. It expects to report revenue for 2021 of $220 million to $225 million, a rise of 20%-23% from 2020.

Shares at 1216 GMT were down 14.0 pence, or 8.4%, at 152.0 pence.

Write to Ian Walker at [e-mail]

(END) Dow Jones Newswires

November 23, 2021 08:06 ET (13:06 GMT)

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