FDA Grants Fast Track Designation to Idiopathic Pulmonary Fibrosis Therapy

Officials with the FDA have granted Fast Track designation to pamrevlumab for the treatment of patients with idiopathic pulmonary fibrosis (IPF), according to a FibroGen press release.

Pamrevlumab, developed by FibroGen, is a first-in-class antibody that works by inhibiting the activity of connective tissue growth factor (CTGF). CTGF is common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure, according to the company.

The designation is based on an FDA review of phase 2 clinical trial results that evaluated the therapy compared with a placebo. Pamrevlumab has also been granted Orphan Drug Designation.

According to a continuing education symposium presented at the Asembia Specialty Pharmacy Summit 2018, IPF remains difficult to diagnose and manage because of its unknown etiology, varied clinical course, associated comorbidities, and nonspecific respiratory symptoms. If approved, pamrevlumab has the potential to address an unmet medical need for the disease.

IPF, a form of progressive pulmonary fibrosis, causes tissue scarring that leads to irreversible loss of lung function, contributing to high morbidity and mortality rates. According to FibroGen, the average life expectancy is estimated to be 3 to 5 years from diagnosis, with approximately two-thirds of patients dying within 5 years.

“The Fast Track designation reflects recognition of the great need for a new therapeutic to help patients diagnosed with IPF to reduce the burden and progression of this debilitating disease and another positive step in developing pamrevlumab for the treatment of IPF,” Elias Kouchakji, MD, senior vice president, clinical development and drug safety, said in a prepared statement.

According to Dr Kouchakji, pamrevlumab is advancing towards phase 3 clinical development for IPF early next year.

Pamrevlumab has also received Fast Track designation for pancreatic cancer and is currently in a phase 2 trial for Duchenne muscular dystrophy.

Reference

FibroGen Receives Fast Track Designation From the U.S. FDA for Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis [news release]. FibroGen’s website. http://phx.corporate-ir.net/phoenix.zhtml?c=253783&p=irol-newsArticle&ID=2367094. Accessed September 14, 2018.