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news.Insmed, a biopharmaceutical company, has received notification from the US FDA on the continuation of the clinical hold previously placed on phase 3 clinical trial for Arikace (liposomal amikacin for inhalation) to treat non-tuberculous mycobacterial (NTM) lung disease.
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The clinical holds placed on the trial were based on an initial review by FDA of the interim results of a long-term rat inhalation carcinogenicity study reported to the agency.
FDA had requested additional information on Arikace and data from the rat study as it had insufficient information to assess the risks of Arikace in NTM patients in the planned phase 3 clinical trial.
The agency has called for a phase 2 clinical trial in adult NTM patients intended to provide proof-of-concept efficacy and safety data for Arikace before the company can proceed with a phase 3 clinical trial.