OREANDA-NEWS. December 15, 2015. NINLARO® (ixazomib) capsules, the first and only oral proteasome inhibitor, are now available in the United States. NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Takeda Pharmaceutical Company Limited (TSE: 4502) recently received U.S. Food and Drug Administration (FDA) approval for NINLARO, four months prior to its Priority Review PDUFA date. NINLARO is a once-weekly pill for three weeks of a four week cycle. More information is available at www.NINLARO.com.

“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 timeframe,” said Christophe Bianchi, M.D., President, 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.”

NINLARO is a pill that can be taken at home which may reduce some of the logistical burden for patients, because administration does not require an infusion or injection at a hospital, clinic or physician’s office. For patients prescribed NINLARO, Takeda is offering NINLARO 1Point, a comprehensive support program offering an array of access and coverage services. More information about NINLARO 1Point is available through www.NINLARO.com or by calling 1-844-N1POINT (1-844-617-6468).

“Access to therapy for patients in need is our first and foremost priority,” said 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.  Additionally, there is a specialty pharmacy network to assist patients and healthcare providers. The following specialty pharmacies are in the NINLARO 1Point network:

Pharmacy

Telephone Number

Accredo Specialty Pharmacy

1-877-732-3431

Advanced Care Scripts (ACS)/

Omnicare Specialty Care Group

1-877-985-6337

Avella Specialty Pharmacy

1-877-546-5779

Axium Healthcare Pharmacy, Inc.

1-888-315-3395

Biologics, Inc.

1-800-856-1984

CVS/specialty

1-800-237-2767

Diplomat Pharmacy, Inc.

1-877-977-9118

US Bioservices

1-877-757-0667

Walgreens

1-888-380-6188