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FDA Lifts Clinical Hold on Insmed (INSM) ARIKACE in NTM Patients; Continues CF Negotiations

January 20, 2012 8:03 AM EST Send to a Friend
Insmed Incorporated (Nasdaq: INSM), announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on ARIKACE (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease. Insmed continues to engage in discussions with FDA regarding the clinical hold placed on ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas lung infections.

The clinical holds placed on the ARIKACE programs in NTM and CF were based on an initial review by FDA of the results reported by Insmed of a long-term rat inhalation carcinogenicity study of ARIKACE.

FDA previously requested that Insmed conduct a phase 2 clinical trial of ARIKACE in adult patients with NTM to provide proof-of-concept efficacy and safety data before proceeding with a phase 3 clinical trial. As part of its on-going assessment of the appropriate path forward for the ARIKACE program, including the phase 2 trial of ARIKACE in NTM patients, the Company is continuing communication with FDA regarding the CF clinical hold.

Insmed also announced that it will move ahead with the 9-month dog inhalation toxicity study of ARIKACE as previously requested by FDA to determine if the findings of the rat inhalation carcinogenicity study are observed in a non-rodent model.




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