Insmed has announced that it anticipates discussions with the EMA by the end of 2013 regarding Arikace inhaled liposomal amikacin for the treatment of nontuberculous mycobacterial (NTM) lung disease and that it has already initiated the Scientific Advice Working Party (SAWP) process. The company says that it is also looking to take advantage of a “globally uncontested orphan disease market” in considering commercialization of Arikace in other countries, including Japan.
Arikace is currently in development for the treatment of NTM lung infections, and Insmed announced that it has completed patient enrollment in a Phase 2 study for that indication in the US and Canada. Insmed President and CEO Will Lewis said, “Completing enrollment of this trial is a major accomplishment for Insmed, particularly given the challenge of enrolling patients who have completed six months on ATS/IDSA guideline therapy. The current tolerability challenges of the guideline therapy limit the practical utility of the ATS/IDSA recommended treatment regimen and are the reason why approximately half of diagnosed NTM patients do not receive or continue to take the recommended off label therapies.”
Lewis added, “Importantly, recent US regulatory designations underscore the importance the FDA places on helping to advance critically needed antibiotics for serious infections such as NTM. Pursuant to our QIDP status, we expect to continue our ongoing dialogue with the FDA regarding the regulatory pathway for registration and approval of Arikace to treat NTM. We remain on track to review and release the clinical data and related dialogue with the FDA by the end of the first quarter of 2014.”
The FDA granted orphan status to Arikace for the treatment of NTM March 2013. The product also received Fast Track and Qualified Infectious Disease Product (QIDP) designations from the FDA in June 2013.
Read the Insmed press release.
