Feb 25 (Reuters) - InterMune Inc’s experimental drug, in a late-stage trial, reduced the progression of a disease that leads to loss of lung function, taking the treatment closer to U.S. marketing approval.
The drug, pirfenidone, was rejected by the U.S. Food and Drug Administration in May 2010, citing lack of data to prove its efficacy in treating idiopathic pulmonary fibrosis (IPF), a potentially fatal lung disease.
The health regulator had asked InterMune to conduct a new trial and the late-stage study, named Ascend, was drawn up to support the drug’s U.S. marketing clearance.
The trial compared pirfenidone with a placebo and showed that after 52 weeks of treatment, 16.5 percent of patients in the pirfenidone group experienced disease progression compared with 31.8 percent in the placebo group.
The study also showed that 22.7 percent of patients getting the drug experienced no decline in lung function compared with 9.7 percent in the placebo group.
Pirfenidone had a favorable safety profile and was generally well tolerated, InterMune said.
The drug is already approved to treat IPF in Europe and Canada, where it is marketed as Esbriet. It is also approved in Japan, South Korea, China, India, Argentina and Mexico.
IPF is an irreversible condition that leads to progressive loss of lung function due to scarring, which hinders the lungs’ ability to absorb oxygen.
InterMune said it expected to resubmit its marketing application for the drug to the FDA by early third quarter of this year.
The company’s shares closed at $13.96 on the Nasdaq on Monday.