EMA stalls B-VEC marketing authorization for dystrophic epidermolysis bullosa

Key takeaways:

• Krystal Biotech submitted a marketing authorization application to the European Medicines Agency for dystrophic epidermolysis bullosa last year.
• The Agency has cancelled its oral explanation of the application.

The European Medicines Agency’s Committee for Medicinal Products for Human Use cancelled the oral explanation for beremagene geperpavec-svdt’s marketing authorization application, Krystal Biotech announced in a press release.

Approved in the U.S. for the treatment of dystrophic epidermolysis bullosa (DEB), beremagene geperpavec-svdt (B-VEC) has been under review by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use for the same indication since the agency validated its marketing authorization application in late 2023.

However, the previously scheduled oral explanation of this application was postponed from its original Dec. 6 date until the company submits written responses to “remaining outstanding issues,” according to the press release.

“We are confident in our ability to address the remaining post-marketing issues, and we believe that this additional exchange with EMA will ultimately maximize benefit and convenience to patients suffering from DEB,” Suma Krishnan, MS, president of research and development at Krystal Biotech, said in the release.

According to the release, the outstanding issues are not major objections regarding the full approval of B-VEC. The company expects the committee to release its opinion early next year and still plans to launch B-VEC in the second quarter of 2025 in Germany.

Reference:

• Krystal Biotech announces EMA validation of marketing authorization application for Vyjuvek for the treatment of dystrophic epidermolysis bullosa. https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-ema-validation-marketing-authorization. Published Nov. 27, 2023. Accessed Dec. 11, 2024.