CAMBRIDGE, Mass. — Takeda Pharmaceutical Co. has released Ninlaro capsules (ixazomib), a blood cancer medication, in the United States.
Takeda said Friday that Ninlaro is the first and only oral proteasome inhibitor. In combination with lenalidomide and dexamethasone, Ninlaro is indicated for the treatment of patients with multiple myeloma, a plasma cell cancer, who have received at least one prior therapy.
The Food and Drug Administration approved Ninlaro four months before its Priority Review PDUFA (Prescription Drug User Fee Act) date, Takeda noted.
“With Ninlaro now available in the U.S., we have taken our extensive research and turned it into a reality. In addition to the clinical investigators and patients, I would like to extend our thanks to the FDA for its expedited review of Ninlaro. The need for new and differentiated treatment options is urgent, and their commitment allowed us to bring Ninlaro to market within a rapid time frame,” stated Christophe Bianchi, president of Takeda Oncology. “In the short time since receiving FDA approval of Ninlaro, we have seen an enthusiastic reception from providers and patients alike. In fact, prescriptions have already been written by physicians and approved by insurers. We are excited to realize our commitment to the multiple myeloma community as we bring Ninlaro to patients.”
A once-weekly pill for three weeks of a four-week cycle, Ninlaro can be taken at home, which Takeda said may reduce some of the logistical burden for patients because administration doesn’t require an infusion or injection at a hospital, clinic or doctor’s office. For patients prescribed Ninlaro, Takeda is offering Ninlaro 1Point, a support program offering an array of access and coverage services.
“Access to therapy for patients in need is our first and foremost priority,” commented Ryan Cohlhepp, vice president of U.S. marketing at Takeda. “And with Ninlaro 1Point, we have created a robust suite of support services to help patients access Ninlaro.”
Ninlaro is available through an open distribution model that includes physician in-office dispensing, as well as through a specialty pharmacy network to assist patients and health care providers. Specialty pharmacies in the Ninlaro 1Point network include Accredo, ACS/Omnicare, Avella, Axium, Biologics Inc., CVS/specialty, Diplomat, US Bioservices and Walgreens.
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