InterMune is celebrating after getting the thumbs-up from regulators in Europe for its idiopathic pulmonary fibrosis treatment Esbriet.
Specifically, the European Commission has granted marketing authorisation for Esbriet (pirfenidone) for the treatment of mild to moderate IPF, a lung disease which affects more than 100,000 patients in Europe. InterMune plans to launch the drug "on timelines consistent with normal regulatory and reimbursement processes" in the various European nations of the EU, starting this year.
In connection with the approval, the company has committed to conduct a post-authorisation safety study to monitor adverse drug reactions in some 1,000 patients, plus a trial to determine the impact of the antibiotic ciprofloxacin on the pharmacokinetics and safety of Esbriet in 25 healthy subjects. Intermune will also implement a risk management plan.
The company quoted Roland du Bois of Imperial College, London, and co-chair of the Esbriet Phase III clinical programme, as saying that IPF has an estimated survival rate of only 20% after five years, "which makes it more lethal than many cancers, and yet no therapeutic interventions have been approved". As such, the green light for Esbriet is "a landmark event”.
InterMune chief executive Dan Welch called the approval "an historic moment in the treatment of IPF patients...but also an exciting new chapter for our company as we now transition to become an international commercial organisation".
Esbriet is already marketed in Japan as Pirespa by Shionogi but it has found the US approval pathway more rocky. In May last year, the Food and Drug Administration rejected pirfenidone despite its Pulmonary-Allergy Drugs Advisory Committee voting 9-3 to recommend approval two months earlier.