Fibrosis Suffers Await FDA Pirfenidone Ruling

28 April 2010 (Last Updated April 28th, 2010 18:30)

The Coalition for Pulmonary Fibrosis (CPF), along with thousands of sufferers in the US, are eagerly awaiting an upcoming decision by the US FDA, which could see Pirfenidone become the first approved therapy for the lethal lung disease. An FDA Advisory Committee recommended the approval

The Coalition for Pulmonary Fibrosis (CPF), along with thousands of sufferers in the US, are eagerly awaiting an upcoming decision by the US FDA, which could see Pirfenidone become the first approved therapy for the lethal lung disease.

An FDA Advisory Committee recommended the approval of the drug on March 9, 2010, for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce a decline in lung function.

Marketed as Esbriet (Pirfenidone) by InterMune, the new drug has received orphan drug, fast-track and priority-review designations by the FDA. A target date of May 4, 2010, has been set under the Prescription Drug User Fee Act (PDUFA).

The CPF has supported, on behalf of researchers and patients, research efforts by the pharmaceutical industry and the National Institutes of Health (NIH).

Pulmonary fibrosis (PF) is a lung disorder characterised by a progressive scarring and deterioration of the lungs affecting an estimated 48,000 patients each year.