- Irish commercial-stage biopharma Amryt ( NASDAQ: AMYT ) on Thursday said UK's drug regulator had approved its Filsuvez gel to treat wounds associated with genetic skin disorder epidermolysis bullosa (EB).
- U.S.-listed shares of AMYT were 3.5% higher at $7.93 in premarket trading.
- The UK's Medical Healthcare & Products Regulatory Agency granted a marketing authorization and an orphan drug designation to Filsuvez for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients 6 months and older, AMYT said in a statement .
- "We look forward to continuing our discussions with the reimbursement agencies across the UK and European Union to begin delivering Filsuvez to treat patients as soon as possible...," AMYT CEO Joe Wiley said.
- The nod from the British regulator comes after the European Commission approved Filsuvez in Aug.
- The U.S. FDA rejected the company's approval application for Filsuvez in Feb., with Amryt ( AMYT ) later saying it would appeal the so-called complete response letter.
For further details see:
Amryt gets British marketing approval & orphan drug designation for rare skin disease gel