FDA Clinical Hold Continues for Insmed's (INSM) ARIKACE

Insmed Incorporated (Nasdaq: INSM), has been notified by the U.S. Food and Drug Administration (FDA) 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 (CF) 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.

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 the Company, including that Insmed conduct a dog inhalational 9-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.

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