FDA grants Breakthrough Therapy Designation for Roche ’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease

Basel, 3 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Esbriet ® (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). The designation was granted based on data from a Phase II trial, which studied the efficacy and safety of Esbriet in uILD[1]. The study represented the first randomised controlled trial to exclusively enroll patients with progressive fibrosing uILD.“Today’s milestone for Esbriet builds on our continued commitment to improving the standard of care for people living with fibrotic lung diseases,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to discussing the data with the FDA with the hope of bringing our important medicine to those with uILD who are currently without a treatment option.” ILD is a term that broadly describes a diverse group of more than 200 types of rare pulmonary diseases. While ILDs share similar features, including cough and shortness of breath, each ILD has different causes, treatment approaches, and outlooks.[2] Approximately 10% of people living with ILD reviewed by a multidisciplinary team cannot be given a definitive diagnosis, even after a thorough investigation, and in these cases, patients are categorised as having uILD[3,4]. The Phase II data supporting Breakthrough Designation...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news

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