What's Happening?
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Brinsupri, a drug developed by Insmed, for the treatment of non-cystic fibrosis bronchiectasis (NCFB). This condition
is characterized by thickened and damaged airway walls due to inflammation and infections. Brinsupri, a DPP1 inhibitor, is intended for patients aged 12 and older who have experienced two or more exacerbations in the past year. The drug has shown promise in reducing the number of exacerbations by 29% compared to a placebo, based on the ASPEN trial. The European Commission is expected to approve Brinsupri soon, and Insmed plans to introduce the drug in Japan next year.
Why It's Important?
The approval of Brinsupri is significant as it addresses a critical need for effective treatments for NCFB, a condition affecting between 400,000 and three million people in the EU. The drug's ability to reduce exacerbations and improve patient outcomes could lead to better quality of life and reduced healthcare costs associated with repeated infections and hospitalizations. Insmed anticipates that the high prevalence of NCFB could drive Brinsupri's sales to exceed $5 billion annually. This development also highlights the ongoing efforts to provide innovative treatments for chronic and debilitating diseases.
What's Next?
Following the CHMP's recommendation, the European Commission is expected to grant approval for Brinsupri in the coming weeks. Insmed is also preparing to launch the drug in the Japanese market next year. The company will likely focus on expanding its market presence and ensuring accessibility for patients who could benefit from this treatment. Additionally, Sanofi has a 15-day window to request a re-examination of the CHMP's decision regarding its drug Rezurock, which was not recommended for approval.
