FDA Approves Two Drugs for Little-Understood Lung Condition

October 21, 2014

The FDA last week approved two breakthrough therapies for idiopathic pulmonary fibrosis:  Boehringer Ingelheim’s Ofev and Intermune’s Esbriet, both of which are set to hit the market within the next two weeks, the companies said.

While the exact causes of the rare and fatal disease are unknown, both Ofev (nintedanib) and Esbriet (pirfenidone) are thought to inhibit multiple pathways, such as growth factor receptors, which are involved in IPF’s progressive scarring of the lungs, according to Tunde Otulana, BI’s senior vice president of clinical development and medical affairs.

Until now, the only treatments available were supplemental oxygen and lung transplants, neither of which actually treat the disease itself, Otulana said. The disease affects up to 132,000 people in the U.S., and most patients die within three to five years of diagnosis.

In addition to the breakthrough therapy designation, both products received orphan drug designation and fast-track and priority reviews, the FDA said.

Both drugs were studied in three trials each, involving a combined total of 2,478 patients. According to BI, patients in its trials experienced between 45 percent and 68 percent reduction in loss of lung function, as measured by the amount of air forcibly exhaled after taking a full breath.

BI said it plans to launch Ofev this week while Intermune said Esbriet will be available within 10 days. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.