Timely Lancet appearance for Italfarmaco’s givinostat

Italfarmaco has announced that results from its pivotal Phase III EPIDYS trial with givinostat in ambulant boys aged six years and older with Duchenne muscular dystrophy (DMD) have been published in The Lancet Neurology.

The publication comes at a timely moment for the privately-held Italian firm, since the US Food and Drug Administration (FDA) is due to complete its review of givinostat by this week, having previously put back the deadline by three months.

"Givinostat has the potential to benefit a broad DMD patient population independent of the underlying gene mutation"The EPIDYS trial met its primary endpoint of a change in four-stair climb assessment from baseline to 72 weeks, which demonstrated the potential of givinostat to delay disease progression when added to corticosteroid treatment.