Insmed’s (NASDAQ:INSM) Arikayce — amikacin liposome inhalation suspension — has won FDA approval for treating a lung disease caused by mycobacterium avium complex, in a limited population of patients not responding to conventional treatment.
The advisory panel in August failed to broadly back the drug for that application, but it did get an OK as part of a combination for patients with few or no treatment options.
The label has a boxed warning about an increased risk of respiratory conditions.
Bloomberg estimates the drug can bring in 2019 sales of $82.8M, rising to more than $500M by 2022.
Shares were halted at 4:35 p.m. for the pending news and haven’t gotten a reopening time yet.
Updated 6:04 p.m.: Insmed issues a press release about the approval and sets a conference call at 6:15 p.m. (in a few minutes) to discuss it. Insmed says it’s collaborating with the FDA on the design of an additional clinical study to support full approval.
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