March 03, 2020: Roche announced that the U.S.FDA has granted Breakthrough Therapy Designation (BTD) to Esbriet® (pirfenidone) for the adults with unclassifiable interstitial lung disease (uILD).
The designation was granted based on the data from Phase II trial, which studied the efficiency and safety of Esbriet in uILD. The study represented the first randomised controlled trial to entirely 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 describing primarily a diverse group of more than 200 forms of rare pulmonary diseases. Although ILDs share similar symptoms including cough and shortness of breath, each ILD has different causes, approaches to treatment, and outlooks.
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.
Approximately 10 percent of people living with ILD who are examined by a multidisciplinary team can not be offered a definitive diagnosis, even after a thorough investigation, and in such cases patients are classified as having uILD.”
“The Phase II data supporting Breakthrough Designation were just presented as a late-breaking abstract at the 2019 European Respiratory Society’s annual meeting and simultaneously published in The Lancet Respiratory Medicine. The data suggested Esbriet slowed disease progression and supported its efficiency on a number of lung function parameters including forced vital capacity (FVC), in people with uILD. The security and tolerability profile of Esbriet in people with uILD was comparable with that observed in Phase III trials in people with idiopathic pulmonary fibrosis (IPF).
Breakthrough Therapy Designation is designed in order to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies. This is the 33rd Breakthrough Therapy Designation for Roche’s portfolio of the medicines.”
“Esbriet is an oral medicine approved for the treatment of IPF and is available in more than 60 countries worldwide. Esbriet has Orphan Drug designation and was approved for use in Europe in 2011 in adults with mild-to-moderate IPF and in the US in people with IPF in October 2014”. https://www.roche.com/investors/updates/inv-update-2020-03-03.htm