Genentech's Esbriet Granted Breakthrough Therapy Designation for uILD
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Genentech’s Esbriet (pirfenidone) as a potential treatment for adults with unclassifiable interstitial lung disease (uILD) as the Roche subsidiary looks to expand its indications.
The FDA granted the designation based on data from a mid-stage trial that examined the safety and efficacy of Esbriet in this indication. Interstitial lung disease is a term that covers a broad range of more than 200 types of rare pulmonary diseases. The Phase II study represented the first randomized controlled trial to exclusively enroll patients with progressive fibrosing uILD, Genentech said. Data from the trial were recently presented as a late-breaking abstract at the 2019 European Respiratory Society’s annual meeting and simultaneously published in The Lancet Respiratory Medicine. Some of the key trial results suggest that treatment with Esbriet slowed the progression of the disease and also indicated efficacy on a number of lung function parameters including forced vital capacity (FVC) at 24 weeks in people with uILD, Genentech said.
Esbriet inhibits with the production of Transforming Growth Factor-beta, a small protein in the body involved in how cells grow and Tumor Necrosis Factor (TNF)-alpha, a small protein that is involved in inflammation.
Levi Garaway, chief medical officer and head of Global Product Development for Roche, the parent company of Genentech, said the Breakthrough Therapy designation builds on the company’s commitment to improving the standard of care for people with fibrotic lung diseases. Esbriet is already FDA-approved for the treatment of idiopathic pulmonary fibrosis.
“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,” Garaway said in a statement.
There are a number of commonalities among the varying pulmonary diseases that fall under the ILD umbrella, including cough and shortness of breath. Each of these diseases though has different causes, treatment approaches, and outlooks, Genentech said. The company added that “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, people are categorized as having uILD.”
Roche acquired Brisbane, Calif.-based InterMune, the company that developed the drug in an $8.3 billion deal. Esbriet was approved by the U.S. Food and Drug Administration two months after the acquisition was announced. The only other approved therapy for IPF is Boehringer-Ingelheim's Ofev (nintedanib). Last year, Biogen halted the development of its IPF treatment due to safety concerns.
With the awarding of Breakthrough Therapy designation for Esbriet, Genentech noted it was the 33rd time the FDA has granted the designation to its portfolio of medicines. The designation is aimed at accelerating the development and review of treatments for treat serious or life-threatening conditions.