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|NINLARO® (ixazomib) Now Available for Patients|
Takeda’s NINLARO is the first and only oral proteasome inhibitor, backed by a clinically demonstrated safety and efficacy profile
Cambridge, Mass. and Osaka, Japan, December 11, 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:
To arrange for in-office dispensing, offices may call their normal distributor/wholesaler. If unavailable, please call 1-844-N1POINT (1-844-617-6468) for options to arrange for immediate access to product as distribution channels open up.
About NINLARO (ixazomib) capsules
NINLARO (ixazomib) is the first and only oral proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is administered orally, once-weekly on days 1, 8, and 15 of a 28-day treatment cycle. NINLARO is currently under review by the European Medicines Agency (EMA) and was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP). NINLARO also received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory systemic light-chain (AL) amyloidosis, a related ultra orphan disease, in 2014.
The TOURMALINE clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. Five global Phase 3 trials are ongoing:
In addition to the TOURMALINE program, a large number of investigator initiated studies are evaluating ixazomib for patients globally.
Important Safety Information
WARNINGS AND PRECAUTIONS
The most common adverse reactions occurring in greater than or equal to 20% of patients treated with NINLARO were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting and back pain.
DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.
Please see the full Prescribing Information for NINLARO.
About Multiple Myeloma
Additional information about Takeda is available through its corporate website, www.takeda.com.