- 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
