According to Vectura, Mundipharma’s Phase 3 trial of the flutiform fluticasone/formoterol MDI failed to demonstrate statistically significant superiority compared to formoterol alone in reducing moderate and severe COPD exacerbations. Mundipharma had planned to seek approval from European regulators to market flutiform for the treatment of COPD but will now put off filing an application indefinitely.
Flutiform has been approved for the treatment of asthma in the EU since 2012. Mundipharma acquired rights to market flutiform from Skyepharma, which was acquired by Vectura earlier this year.
Vectura CEO James Ward-Lilley commented, “COPD is a complex and highly variable disease and these trial results highlight the challenge in demonstrating reductions of exacerbations with ICS/LABA combinations in today’s treatment environment. Whilst this result is disappointing, flutiform continues to grow strongly based on the approved asthma indication, which continues to underpin our expectations for future growth of the product. Vectura already benefits from sizeable and growing revenues from other partnered products on the market in Europe and elsewhere for the treatment of COPD, including Ultibro and Seebri.”
Read the Vectura press release.
