- Health Canada has accepted the New Drug Submission for Duvyzat (givinostat) and granted Priority Review status, shortening the target review timeline to 180 days for the treatment of Duchenne muscular dystrophy (DMD).
- The filing is supported by the Phase 3 EPIDYS trial, where givinostat plus corticosteroids significantly improved performance on the four-stair climb assessment compared with placebo plus corticosteroids in ambulant boys with DMD.
- Approximately 1,000 boys in Canada are living with DMD, a severe progressive neuromuscular disorder, with limited treatment options currently available to slow functional decline.
- Italfarmaco plans to establish a Canadian affiliate to support regulatory activities and patient access initiatives, with a potential Health Canada approval anticipated before the end of 2026, subject to review outcomes.
Takeaways:
This accelerates Italfarmaco’s commercial entry, giving it a platform to negotiate reimbursement and patient access with a distinct HDAC-inhibitor mechanism and a combination-of-care standard (with steroids), while simultaneously increasing payer scrutiny on pricing across the high-value DMD market as the third approved mechanism class pressures existing therapies and reimbursement thresholds.
Source: Italfarmaco
