Ipsen follows up Sohonos EC rejection with US approval

French drugmaker Ipsen (Euronext: IPN) has won a landmark US approval of Sohonos (palovarotene) for an ultra-rare bone disease, having been rebuffed last month in its efforts to do so in Europe.

The capsules have been approved by the US Food and Drug Administration (FDA) as a retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged eight years and older for females, and 10 years and older for males, with fibrodysplasia ossificans progressiva (FOP).

Sohonos, a novel RARγ agonist, becomes the first treatment for patients with FOP, who number around 400 in the USA and 900 people globally. The drug won its first approval in Canada in January last year and has also been conditionally approved in the United Arab Emirates.