An experimental new drug aimed at tackling a rare lung illness has failed to win approval from the US Food and Drug Administration.
The body has requested a further clinical trial of perfinedone, leaving InterMune’s chief executive Dan Welch “disappointed”.
The FDA was asked to approve perfinedone for people with a stiffening and scarring of the lungs known as idiopathic pulmonary fibrosis, which afflicts around 200,000 people across Europe and the US.
The disease makes breathing difficult, however the cause in unknown.
The Brisbane, California-based firm currently has only one product on the market, Actimmune, which treats a rare immune system disorder and a type of osteoporosis.
Intermune planned to market perfinedone under the brand name Esbriet to the roughly 100 specialists who treat idiopathic pulmonary fibrosis in the US.
There are currently no FDA-approved therapies for idiopathic pulmonary fibrosis. The FDA had granted Intermune’s drug priority review, which is reserved for products that fill an unmet medical need.
Copyright Press Association 2010
The Food and Drug Administration