Company confirms plans to carry out additional Phase III trial to enable resubmission of NDA.
The European Commission has approved InterMune’s Esbriet® (pirfenidone) for the treatment of adults with mild-to-moderate idiopathic pulmonary fibrosis (IPF). The firm claims the drug is the first treatment for IPF to be approved in the EU. Pending anticipated reimbursement timelines, launch of Esbriet in Germany is projected for later this year, followed by roll-out across other major European markets in 2012.
In connection with the EU approval, InterMune will conduct a post-authorization safety study registry and a drug-drug interaction trial to evaluate the effects of the antibiotic ciprofloxacin on the pharmacokinetics and safety of Esbriet in healthy subjects.
Pirfenidone has been granted orphan drug designation in Europe and in the U.S., where the drug has yet to be approved. An NDA for pirfenidone was originally submitted to FDA in 2009, but InterMune subsequently received a complete response letter requesting an additional clinical trial supporting clinical efficacy in IPF patients. In January 2011, the firm reported that it does plan to carry out an additional Phase III study.
Pirfenidone is an orally active, small molecule drug that inhibits the synthesis of TGF-beta, which plays a key role in fibrosis. The drug also inhibits the synthesis of TNF-alpha and has demonstrated activity in multiple fibrotic conditions including those of the lung, kidney, and liver, InterMune claims.
InterMune licensed certain rights to pirfenidone from Marnac and KDL in 2002. During 2007, the firm acquired the rights to sell the compound in the U.S., Europe, and other territories except Japan, Taiwan, and South Korea, where rights have been licensed to Shionogi. Pirfenidone was approved as an IPF therapy in Japan in 2008, where it is marketed by Shionogi as Pirespa®. The IPF clinical development program for pirfenidone comprised multiple Phase II and III trials including two Phase III capacity trials conducted by InterMune, and a Phase III trial designed and conducted by Shionogi.
InterMune claims that although IPF used to be considered a relatively rare disease, it is now recognized as the most common interstitial lung disease. The firm suggests the condition affects an estimated 100,000 in the United States, and more than 30,000 new cases are diagnosed annually.