Abeona shares tumble as FDA declines to approve skin disorder treatment

FILE PHOTO: FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

(Reuters) -Abeona Therapeutics said on Monday the U.S. Food and Drug Administration (FDA) had declined to approve its treatment for a rare skin blistering condition, sending its shares down 51% in after-market trading.

The health regulator sought certain additional data to satisfy requirements pertaining to chemistry, manufacturing, and controls before the treatment, called pz-cel, can be approved, in its so-called "complete response letter".

The drug developer is seeking approval for the treatment in patients with recessive dystrophic epidermolysis bullosa, where the skin becomes fragile and blisters can appear through rubbing or exposure to heat.

Abeona said it expects to complete and submit the requested information in the third quarter.

FDA in its response letter indicated that the proposed timing of the data submission would not allow sufficient time to complete its review by May 25, the set deadline to decide on the application.

The company, however, pointed out that the agency did not identify deficiencies related to the treatment's clinical efficacy or clinical safety data, and has requested no new studies to support approval.

Pz-cel's application for approval is based on data from a late-stage and early-to-mid-stage study.

"Both studies demonstrate that a single application of pz-cel on large and chronic wounds will deliver sustained wound healing and pain reduction", company said in a statement.

The health regulator had last year approved Krystal Biotech's, Vyjuvek, the first-of-its kind topical gene therapy for patients with a less dominant form of the disease.

(Reporting by Pratik Jain in Bengaluru; Editing by Sriraj Kalluvila)