Insmed Drug Gets Green Light from FDA
Insmed Incorporated (NASDAQ:INSM) shares leap 26 percent following an announcement that the U.S. Food and Drug Administration has removed the clincal hold previously placed on the company’s Arikace drug for treating non-tuberculous mycobacteria lung disease.
The biopharmaceutical company is still in discussions with the FDA regarding the clinical hold placed on Arikace in Cystic Fibrosis patients with Pseudomonas lung infections.
The clinical holds stemmed from the FDA’s preliminary review of the results of a long-term rat inhalation carcinogenicity study of the drug reported by Insmed.
According to Insmed President and CEO Timothy Whitten, the company is beginning a new study on the drug using dogs and is continuing “dialogue with FDA regarding the CF clinical program.”