FDA ap­proves Chiesi’s gel for rare skin dis­ease af­ter ini­tial 2022 re­jec­tion for Am­ryt

Cer­tain chil­dren with the rare skin dis­ease epi­der­mol­y­sis bul­losa now have a treat­ment op­tion thanks to an FDA ap­proval for Chiesi Glob­al Rare Dis­eases’ top­i­cal gel Fil­su­vez.

Chiesi said Tues­day the FDA green­lit the gel for treat­ing par­tial thick­ness wounds in pa­tients as young as 6 months old who have forms of EB known as junc­tion­al (JEB) and dy­s­troph­ic (DEB). Fil­su­vez is the first treat­ment ap­proved for wounds as­so­ci­at­ed with JEB, Chiesi said. Krys­tal Biotech’s Vyju­vek was ap­proved for the DEB form in May, mak­ing it the first gene ther­a­py to be ap­plied top­i­cal­ly.

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