- The application of the marketing authorization is supported by results from the Phase 3 TETON-1 and TETON-2 studies1
- IPF is a progressive, life-threatening lung disease that continues to pose significant challenges for patients and healthcare systems, highlighting the need for additional treatment options
Ferrer today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for nebulised treprostinil for the treatment of idiopathic pulmonary fibrosis (IPF), marking the start of the agency's formal review process.
The application was based on positive results from the Phase 3 TETON-1 and TETON-2 studies1. Combined analyses of TETON-1 and TETON-2 met the primary efficacy endpoint, with nebulised treprostinil demonstrating statistically significant superiority over placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52 in an IPF population broadly treated with background antifibrotic therapy. The combined analyses also showed that the drug achieved positive results on most key secondary endpoints, including reduced risk of a clinical worsening event and reduced risk of acute IPF exacerbation, among others.
“The acceptance of our application for review marks an important step in our efforts to bring a potential new treatment option to people living with idiopathic pulmonary fibrosis, a progressive and life-threatening disease with significant unmet needs. This milestone reflects Ferrer’s commitment to developing transformative solutions for people affected by serious and debilitating diseases,” said Mario Rovirosa, CEO of Ferrer.
About nebulised treprostinil in idiopathic pulmonary fibrosis
Nebulised treprostinil is being investigated for the treatment of idiopathic pulmonary fibrosis (IPF). The TETON-1 and TETON-2 studies were multicentre, randomised, double-blind, placebo-controlled Phase 3 registration studies evaluating the safety and efficacy of the compound in patients with IPF over a 52-week period. It has not been approved for the treatment of IPF by the EMA and remains investigational for this indication.
Ferrer holds the worldwide distribution rights (except for the U.S., Canada, China, Japan and Israel) for nebulised treprostinil inhalation solution.
Forward-looking statements
Nebulised treprostinil has not been approved by the EMA for any indication, including for the treatment of idiopathic pulmonary fibrosis, and remains investigational for this indication.
This press release contains forward-looking statements regarding the development and regulatory review of nebulised treprostinil in IPF. Such statements are based on current expectations and involve risks and uncertainties. Regulatory authorities may determine that additional data is required or may not approve the application. No assurance can be given regarding the outcome or timing of the regulatory review process.
- Nathan SD, Behr J, Cottin V, Smith PM, Deng C, Rao Y, Breytenbach N, Bell H, Peterson L, Flaherty KR. Inhaled treprostinil in idiopathic pulmonary fibrosis: results from the TETON phase 3 trials. N Engl J Med. 2026