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Esbriet, Ofev Approved to Treat Deadly Lung Disease
Drugs help slow decline of idiopathic pulmonary fibrosisThursday, October 16, 2014
THURSDAY, Oct. 16, 2014 (HealthDay News) -- Two new drugs have been approved by the U.S. Food and Drug Administration to treat progressive lung scarring from an uncertain cause, medically called idiopathic pulmonary fibrosis (IPF).
Approval was given to Esbriet (pirfenidone) and Ofev (nintedanib), the agency said in news releases on Wednesday.
Symptoms of IPF include shortness of breath, cough and difficulty engaging in everyday activities. Current treatments include supplemental oxygen, lung transplant or lung rehabilitation.
Esbriet, produced for Brisbane, Calif.-based InterMune Inc., was evaluated in three clinical trials involving 1,247 people with IPF. The most common side effects included nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue and headache.
Esbriet shouldn't be taken by people with severe liver problems or severe kidney disease, including people on dialysis, the FDA said.
Ofev, distributed by Boehringer Ingelheim of Ridgefield, Conn., was evaluated in clinical studies of 1,231 people with IPF. It's not recommended for people with moderate-to-severe liver problems or among women who may become pregnant. Since Ofev can cause birth defects, women who are able to become pregnant should use contraception for at least three months after the last dose of Ofev, the FDA said.
The most common side effects of Ofev included diarrhea, nausea, abdominal pain, vomiting, elevated liver enzymes, weight loss and loss of appetite.
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