NAPSR News: FDA approves two therapies to treat idiopathic pulmonary fibrosis (IPF)

WASHINGTON - Oct. 16, 2014 - PRLog -- The U.S. Food and Drug Administration has approved two new therapies for the treatment of idiopathic pulmonary fibrosis (IPF) these are Roche’s Esbriet (pirfenidone) and Boehringer Ingelheim’s  OFEV™ (nintedanib*). This signifies a historic moment for the IPF population as Esbriet and OFEV are the first drugs to ever receive regulatory approval to treat IPF in the United States.

IPF (idiopathic pulmonary fibrosis) is a serious and fatal lung disease that causes permanent scarring of the lungs. The formation of scar tissue is medically referred to as fibrosis. IPF affects as many as 14-43 people per 100,000 worldwide. Patients with IPF usually experience shortness of breath, dry hacking cough, fatigue, weightloss and aching muscles and joints. There is no known cure for IPF and current treatment options include oxygen therapy, pulmonary rehabilitation, and lung transplant. Patients with this disease usually live only about 3 to 5 years after diagnosis. Due to the high unmet medical need, both therapies, Esbriet (pirfenidone) and OFEV (nintedanib) were granted FDA Fast Track priority review, orphan product, and breakthrough designation.

The approval of Esbriet stems from clinical data revealing a delay in the in the decline of lung function compared to those who received placebo based on the primary endpoint of percent change in Forced Vital Capacity (FVC). According to Boehringer Ingelheim, OFEV™ reduced the annual decline in lung function by approximately 50% and also reduced the risk of IPF exacerbations – events of acute respiratory worsening.

"It is a historic for IPF patients with two first-ever treatments for IPF being approved by the FDA," said Mishka Michon, chief executive of the Coalition for Pulmonary Fibrosis "With these therapies comes hope for a brighter future for patients and renewed optimism regarding the battle against IPF amongst physicians and researchers."

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