CHMP Recommends Roche Update Esbriet Labeling

European Medicines Agency evaluators have recommended labeling updates for Roche’s rare lung disease therapy Esbriet to include information on the drug’s mortality benefit.

The Committee for Medicinal Products for Human Use said labeling for Esbriet (pirfenidone), which treats idiopathic pulmonary fibrosis (IPF), may reflect analysis of clinical studies that showed the drug reduced all-cause mortality by 48 percent and treatment-emergent IPF-related mortality by 68 percent, Roche said.

Labeling also may include data from a trial that showed 17 percent of patients on the drug lost more than 10 percent of lung function, as compared with 32 percent of patients on placebo. That same study also showed patients on Esbriet had greater progression-free survival.

The added information reinforces the drug’s safety and efficacy profile, Roche spokeswoman Ulrike Engels-Lange said.

IPF, which affects roughly 110,000 people in the EU and 100,000 in the U.S., causes irreversible scarring of the lungs that usually results in death within two to five years of diagnosis. Esbriet is among the few drugs available that target proteins that are thought to be responsible for the scaring.

The drug received EMA approval for mild to moderate IPF in 2011, and the FDA followed suit earlier this month. — 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.