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French health body approves pulmonary fibrosis drug

(Reuters) – InterMune, Inc said the French health authorities ruled in favor of reimbursing the company’s drug Esbriet (pirfenidone) for patients with mild to moderate idiopathic pulmonary fibrosis.

The ruling by The Transparency Commission of the French National Health Authority comes after a German reimbursement body in late February ruled that Esbriet provided additional benefit to patients suffering from the disease.

The French commission has recommended that Esbriet be reimbursed as a “medicament d’exception,” which means that it will be reimbursed only for the labeled indication, that is, for IPF patients with forced vital capacity (FVC) >50% and diffusing capacity (DLco) >35%.

The commission also recommended that InterMune collect information in the form of a patient registry regarding the use of Esbriet in clinical practice.

InterMune said Esbriet was granted an Amelioration du Service Medical Rendu (ASMR) rating of level IV, which means the authority believes the drug provides a minor clinical benefit compared to existing therapies.

The company said it would now start determining the price and is looking at the reimbursement conditions for Esbriet in France, to make the drug available to the country’s patients “as soon as possible.”

A phase III trial of the drug is currently enrolling patients in the U.S.