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news.The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization of InterMune for Esbriet (pirfenidone) in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
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The committee’s positive opinion will now be forwarded to the European Commission for ratification, which typically occurs within two to three months from adoption of the CHMP opinion.
InterMune said that Esbriet has been granted Orphan Drug designation in Europe, which provides 10 years of marketing exclusivity; until 2021.
InterMune president and CEO Dan Welch said that they are very pleased by the positive opinion adopted by the CHMP, particularly because it was achieved earlier in the regulatory process than is typical.
"We are now focusing our efforts on completing our commercial launch preparations to bring Esbriet to European patients as soon as possible," Welch said.