US breakthrough status for InterMune’s pirfenidone

US biotech firm InterMune’s (Nasdaq: ITMN) Esbriet (pirfenidone) has been granted Breakthrough Therapy designation from the US Food and Drug Administration. The announcement of Friday caused a 2.7% rise to $41.70 in InterMune’s shares.

This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

In May, InterMune resubmitted its New Drug Application for pirfenidone and noted a target FDA review of six months under the Prescription Drug User Fee Act. The US FDA declined to clear marketing of pirfenidone back in2010. Pirfenidone is an investigational treatment for adult patients with idiopathic pulmonary fibrosis (IPF), a rare and poorly understood lung condition that causes scarring of the lungs, making it increasingly difficult to breathe.