According to Insmed Incorporated, the US FDA has granted orphan drug designation to its Arikace liposomal amikacin for inhalation for the treatment of non-tuberculous mycobacteria (NTM) infections. Insmed is also developing Arikace for the treatment of P. aeruginosa infections in cystic fibrosis patients. The company also has announced the appointment of Matthew Pauls as its new Chief Commercial Officer.
Insmed President and CEO Will Lewis commented on the orphan drug designation, “The FDA’s timely approval of our request for orphan drug designation for Arikace to treat non-tuberculous mycobacteria is a key milestone that supports our broader strategy for this potentially life-saving therapy. NTM is a chronic, debilitating disease, and currently available treatments have shown limited efficacy and tolerability. We continue to enroll patients in our Phase 2 clinical trial of Arikace to treat NTM patients in the US and Canada and look forward to having top-line data by the end of this year.”
Regarding the appointment of Matthew Pauls, Lewis said, “We are delighted to have an executive of Matt’s caliber join the Insmed team. His experience in successfully launching and building several global product portfolios makes him ideally suited to lead our commercial efforts as Arikace advances through key clinical and regulatory milestones. As we near data readouts for both our Phase 3 clinical trial in CF and our Phase 2 clinical trial in NTM, we are expanding our senior leadership with experienced executives with proven track records of consistently superior performance. With his results-driven background and market knowledge, Matt surely will be a valuable asset to our team.”
Read the Insmed press release on the orphan drug designation.
Read the Insmed press release on the appointment of Matthew Pauls.
