FDA lifts hold on Insmed Arikace trial

23 January 2012

USA-based biopharma company Insmed’s (Nasdaq CM: INSM) shares leapt 33.7% to $5.08 on Friday, after the company revealed that the Food and Drug Administration has lifted the clinical hold previously placed on Arikace (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease.

When the FDA extended its hold last fall on the firm’s Phase III clinical trials for Arikace in cystic fibrosis (CF) patients with Pseudomonas lung infections, Insmed’s shares plunged 32% to $2.05 (The Pharma Letter October 11, 2011).

Insmed says it continues to engage in discussions with the FDA regarding the clinical hold, noting that this was 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 the drug.

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