By Colin Kellaher

Nymox Pharmaceutical Corp. on Monday said the U.S. Food and Drug Administration has turned away the company's new-drug application for a proposed enlarged prostate treatment, with the agency calling for longer-term safety data.

The biopharmaceutical company, which was seeking approval of fexapotide triflutate for the treatment of men with benign prostatic hyperplasia, said it received a "refusal-to-file" letter from the FDA.

According to the FDA's website, a refuse-to-file letter notifies a drug company that the agency won't review a marketing application because of significant deficiencies that can't promptly be resolved, making the application substantially incomplete.

Nymox said the FDA letter involves "some significant inconsistencies," and that it will seek clarification at a follow-up meeting with the agency.

For example, the company said that while the letter indicated that it needs to have longer-term safety data in the application, the agency hadn't requested that data in any previous pre-NDA communications.

Nymox has previously said the last major drug innovations for benign prostatic hyperplasia, an age-related disorder also known as prostate gland enlargement, were first introduced more than 30 years ago.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 23, 2022 09:07 ET (13:07 GMT)

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