FDA Approves Zevaskyn for Rare, Genetic Skin Disorder

Follow Drugslib on

Medically reviewed by Drugs.com.

By Stephanie Brown HealthDay Reporter

TUESDAY, April 29, 2025 -- The U.S. Food and Drug Administration has approved Zevaskyn (prademagene zamikeracel) for patients with the rare, genetic skin disorder recessive dystrophic epidermolysis bullosa.

Zevaskyn is the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa, a skin condition characterized by extremely fragile skin that blisters and tears easily.

FDA approval of Zevaskyn was based on findings from two clinical studies. In a single-center, open-label, phase 1/2a study involving 38 chronic wounds in seven patients, a single surgical application of Zevaskyn demonstrated long-term improvement at the treated sites during a median seven-year follow-up period.

In the multicenter, randomized, intrapatient-controlled, phase 3 VIITAL study, evaluating the effectiveness of a single application of Zevaskyn on 43 large, chronic wounds, 81 percent of wounds demonstrated 50 percent or greater healing after six months. This result was statistically significant when compared with a matched control group of 43 wounds treated with the standard of care, where only 16 percent achieved the same level of healing.

Across both studies, Zevaskyn was well tolerated, and no treatment-related serious adverse events were reported. The most common nonserious adverse events reported were procedural pain and itch, which only appeared to affect about 5 percent of patients.

"Based on the strength of our data across clinical trials, we are confident in Zevaskyn's ability to deliver long-term results after a single treatment application," Madhav Vasanthavada, Ph.D., chief commercial officer at Abeona Therapeutics, said in a statement. "We are committed to working closely with both commercial and government payers on outcome-based agreements that stand behind the promise of Zevaskyn for patients, and expedite access."

Approval of Zevaskyn was granted to Abeona Therapeutics.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2025-04-30 12:00

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords