US FDA approves the manufacturing of rare lung disease treatment

16-Oct-2018 - Last updated on 15-Feb-2024 at 17:29 GMT

(Image: Getty/Gorodenkoff)

Therapure was granted approval for the manufacture of Insmed Incorporated’s drug Arikayce at its Missassauga, Canada facility.

Arikayce, a treatment for mycobacterium avium complex (MAC), a rare and debilitating lung disease, was approved by the US Food and Drug Administration (FDA) in September 2018. Since then, the FDA has granted approval for Insmed Incorporated’s manufacturing partner, Therapure Biomanufacturing to manufacture it.

Therapure Biomanufacturing, a contract development and manufacturing organization (CMO) that is a within Therapure Biopharma, will manufacture the drug in its custom manufacturing suite created through a 2014 commercial agreement with Insmed.

Per the agreement, Therapure became a key manufacturing partner of Arikayce and is responsible for scale-up, commercial aseptic formulation, and fill/finish manufacturing.

Arikayce is the first and only drug approved by the FDA for the specific treatment of MAC. It is approved as part of a combination drug regimen for adult patients.

MAC is a group of bacteria related to tuberculosis that can cause a life-threatening bacterial infection. It is considered an opportunistic infection that can develop after an individual with HIV develops AIDS and have severely suppressed immune systems.