Arikace: FDA hold

Insmed said in its 4Q11 earnings that it submitted a complete response to FDA's requests regarding a clinical hold on Arikace in CF patients, but did not disclose details. Last August, FDA placed a clinical hold on 2 planned trials of Arikace in patients with CF and in patients with non-tuberculosis mycobacteria (NTM) lung infection following undisclosed interim data from a 2-year rat inhalation carcinogenicity study (see BioCentury, Aug. 8, 2011). In October, the agency asked Insmed to propose a CF patient population and disease state where the risk-benefit profile of Arikace may be "more favorable." According to Insmed, the agency also asked the company to conduct a 9-month dog inhalation toxicity study to determine if findings from a rat inhalation carcinogenicity study are also present in a non-rodent model (see BioCentury, Oct. 17, 2011). Insmed said it plans to begin the dog study next quarter. In January, FDA lifted the clinical hold of the product in patients with NTM lung infection but maintained the hold in CF patients (see BioCentury, Jan. 23). ...