Abeona shares tumble as FDA declines to approve skin disorder treatment
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 [April 23, 2024]
(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.
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Signage is seen outside of the Food and Drug Administration (FDA)
headquarters in White Oak, Maryland, U.S., August 29, 2020.
REUTERS/Andrew Kelly/File Photo/File Photo
 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)
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