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Insmed Makes A Case For Accelerated Approval Of First-Line Arikayce Use

Market Up To 5 Times Larger Than Refractory Population

 
• By Mandy Jackson

Insmed’s ARISE trial validated a patient-reported outcome measure it plans to use as the new primary endpoint in the ongoing pivotal ENCORE study, but it will ask the US FDA about accelerated approval based on ARISE. 

Insmed Incorporated reported on 5 September that the Phase III ARISE clinical trial of Arikayce (amikacin liposome inhalation suspension) in patients with newly diagnosed or recurrent nontuberculous mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) who had not started antibiotics validated the patient-reported outcome (PRO) measure that the company now plans to use as the primary endpoint in its pivotal Phase III ENCORE trial. Insmed also plans to ask the US Food and Drug Administration if it can seek accelerated approval in the first-line setting based on ARISE.

If the FDA and other regulators agree to Insmed’s proposal and grant accelerated approval, that could significantly broaden the market for the company’s sole commercial product – approved in 2018 in the US for refractory patients – faster than if it waits for approval based on the ENCORE readout expected in 2025

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