data from 2 Phase III CAPACITY trials show drug safe and well tolerated - in preparation for NDA submission (2/09); mixed results from Phase III data reported 5/09; NDA submitted 11/09 and priority review granted 1/10; FDA advisory board scheduled 3/9/09 with PDUFA date 5/4/10; Advisory board recommends drug in a 9-3 vote (3/10), but was split (7-5) whether it provides a clinically meaningful benefit; MAA submitted to EU 3/10; Complete response letter received 5/10, requiring an additional clinical trial
Brand Esbriet Generic pirfenidone
Company name InterMune Product type Speciality
Therapeutic category Respiratory agents Key uses idiopathic pulmonary fibrosis (IPF)
Other Uses N/A Drug Class Immunomodulator (small molecule)
Dosage From oral Expected Approval 2012+
FDA Filing N/A Last Update date June 10,2010
Link to pipeline report
Link to news article
Link to clinicaltrials.gov