The FDA has approved Chiesi’s Bronchitol mannitol DPI for the treatment of cystic fibrosis in adult CF patients after a lengthy review process. The FDA issued a complete response letter to the original NDA in 2013, and Chiesi re-submitted the application in December 2018. The FDA’s Pulmonary‐Allergy Drugs Advisory Committee (PADAC) voted to recommend approval of the NDA for Bronchitol in May 2019.
Chiesi now says it expects the US launch of Bronchitol to take place in March 2021. The company also distributes the DPI, which was developed by Pharmaxis, in 11 countries outside the US. Bronchitol was approved in Europe in 2012 and is also approved in Australia and Russia.
Chiesi USA CEO Ken McBean commented, “Our teams have worked tirelessly toward today’s FDA approval, and we are thankful that we stayed the course to arrive at this moment. We’re thrilled to achieve this important milestone for the US market and congratulate all Chiesi team members and partners who supported the clinical process.”
Carmen Dell’Anna, Chiesi’s Head of Global Medical Excellence, added, “Bronchitol offers a portable and discreet option for CF management, with no routine cleaning or maintenance of the inhaler device required. We are excited to achieve its approval in the US for adults living with cystic fibrosis.”
Read the Chiesi USA press release.
