
May 22 2023 FDA approves Krystal Bio’s B-VEC for DEB
The FDA has approved the use of Krystal Biotech’s B-VEC (Vyjuvek) in patients with dystrophic epidermolysis bullosa (DEB), both recessive and dominant, aged 6 months or over. The topical gel is the first medicine approved by the FDA for the treatment of DEB. The gel can be administered by a healthcare professional in either a healthcare setting or at home, and is expected to be available in the US by the third quarter of this year.
This is a very important step, and hopefully a step towards even better treatments in the future.
In the EU, Krystal expects to start the Marketing Authorization Application process in the second half of this year. Read more on the Krystal Bio website.
In data presented last month at the Association for Research in Vision and Opthalmology 2023 Annual Meeting, topical application of B-VEC to the eye was well tolerated and associated with full corneal healing by 3 months in a 13 year old patient, treated under a compassionate use programme. Follow-up is ongoing. Read the full press release.