Therapure Biomanufacturing announced approval for the manufacturing of Insmed Incorporated’s Arikayce at its Mississauga facility by the Food and Drug Administration (FDA).
FDA granted accelerated approval of Insmed’s Arikayce (amikacin liposome inhalation suspension) on September 28, 2018, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options.
As one of the key manufacturing partners for Arikayce, Therapure has built a custom manufacturing suite and is responsible for scale-up, commercial aseptic formulation and fill/finish manufacturing, under an agreement signed by the two companies in 2014.
Arikayce is the first and only treatment approved by the FDA specifically for patients with Mycobacterium avium complex lung disease, a chronic and debilitating condition that can significantly increase patient morbidity and mortality. Arikayce manufactured by Therapure is expected to be available in select specialty pharmacies in the coming weeks.
“We are privileged to partner with Insmed in the commercial manufacturing of this important therapy that leverages innovative drug delivery technology to address previously unmet but life-threatening pulmonary diseases,” Nick Green, Therapure’s President and Chief Executive Officer, said. “Therapure prides itself on its development, clinical and commercial cGMP manufacturing expertise providing solutions for biologic therapeutics and innovative drug delivery technologies that make a difference in patients’ lives.”