Pirfenidone Information:

InterMune is a biotechnology company and leading provider of products for the treatment of dieseases, including pulmonary and infectious diseases, and cancer, and is the owner of exclusive rights to the traemark ESBRIET (Pirfenidone). ESBRIET (Pirfenidone) is an investigational drug in the US intended to treat idiopathic pulmonary fibrosis (‘IPF’). InterMune is seeking approval for ESBRIET (Pirfenidone) from the FDA.

InterMune announced on December 17th, 2001 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for Esbriet(TM) (pirfenidone) in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. The CHMP is the scientific body of the EMA responsible for reviewing all Marketing Authorization Applications for new medicines. A summary of the CHMP opinion will be available here: http://tinyurl.com/2am4ubc. Please select "E" to access the Esbriet summary opinion.

The committee's positive opinion will now be forwarded to the European Commission for ratification, which typically occurs within two to three months from adoption of the CHMP opinion. Ratification results in approval for marketing in all 27 member countries of the European Union. Pirfenidone slows tumor cell proliferation by inhibiting fibroblast growth factor, epidermal growth factor, platelet-derived growth factor, and transforming growth factor beta 1.

In October 2010, Indian Company CIPLA has launched PIRFENEX (Pirfenidone 200 mg) in India for treatment of patients with IPF. Complete information on PIRFENEX (Pirfenidone 200mg) can be found as follows:

http://www.cipladoc.com/therapeutic/pdf_cipla/pirfenex.pdf