Insmed Inc., a biopharmaceutical company, today announced that it has been notified by the U.S. Food and Drug Administration that it is continuing the clinical hold previously placed on Insmed's phase 3 clinical trials for ARIKACE® (liposomal amikacin for inhalation) in cystic fibrosis patients with Pseudomonas lung infections.
Insmed has not yet received a response from FDA regarding the clinical hold previously placed on Insmed's phase 3 clinical trials for ARIKACE in patients with non-tuberculous mycobacterial (NTM) lung disease.
As announced on August 1, the clinical holds placed on ARIKACE in CF and NTM were based on an initial review by FDA of the interim results of a long-term rat inhalation carcinogenicity study reported to the agency by Insmed with ARIKACE. At that time, FDA requested additional information on ARIKACE and data from the rat study. Insmed submitted its complete response to this request before the end of August.
Insmed has been informed by FDA that, based on its review of the information provided to date, including the rat inhalation carcinogenicity study results, the agency has insufficient information to assess the risks for ARIKACE in CF patients. FDA has requested additional information from Insmed, including that Insmed conduct a dog inhalational nine-month toxicity study of ARIKACE to determine if the findings of the rat inhalation carcinogenicity study are also demonstrated in a non-rodent model, and to propose a CF patient population/disease state where the risk-benefit profile of ARIKACE may be more favorable.
"Insmed is in the process of assessing the impact that FDA's recent requests and the continuation of the clinical hold will have on our phase 3 clinical trials for ARIKACE in CF," said Timothy Whitten, President and CEO of Insmed. "Once we have a better understanding of the FDA's requests and their implications, we will provide a further update to the market."
Source: Insmed press release