US FDA approves the manufacturing of rare lung disease treatment

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Gorodenkoff)
(Image: Getty/Gorodenkoff)

Related tags Manufacturing Contract manufacturing Infection fill-finish

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.

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