Days after Insmed announced that the FDA was continuing its hold on Phase 3 clinical trials of Arikace inhaled liposomal amikacin for the treatment of cystic fibrosis, the company says that the FDA has also requested additional data on Arikace before continuing a Phase 3 trial in patients with non-tuberculous mycobacterial (NTM) lung disease.
The FDA initially placed clinical holds on Arikace for both indications at the beginning of August 2011 due to concerns raised by its review of data from a rat inhalation carcinogenicity study. Insmed provided additional data by the end of August, but the FDA now says that it still needs more information to evaluate the safety of Arikace and is asking for a new Phase 2 trial of the product in NTM patients before the Phase 3 trial can go ahead.
“Now that we have responses from FDA with respect to both clinical holds, we are seeking further input from the Agency in order to gain a better understanding of their requests regarding CF and NTM. Once we have received clarifications from FDA on their requests, and have sufficient opportunity to evaluate potential next steps, we will provide a further update to the market,” said Insmed President and CEO Timothy Whitten.
Read the Insmed press release.
