Clinigen launches UK managed access program for Takeda’s ixazomib
pharmafile | November 30, 2015 | News story | Sales and Marketing | Clinigen, Takeda, ixazomib, managed access, multiple myeloma, oncology
Clinigen and Takeda have struck a deal to allow patients in the UK to access the multiple myeloma drug ixazomib through a managed access scheme.
Ixazomib is developed and manufactured by Takeda Pharmaceutical Company Limited. It has recently been approved by the FDA in the US, where it is marketed as Ninlaro, for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma, who have received at least one prior therapy.
The European Medicines Agency has accepted a marketing authorisation application for the drug and in July 2015 the Committee for Medicinal Products for Human Use also granted ixazomib accelerated assessment. Ixazomib is the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients of multiple myeloma who have received at least one prior therapy.
The access program will enable individual patients with multiple myeloma that live outside of the US to receive ixazomib in specific countries where the drug is not yet available. In the UK, access to ixazomib will be provided by Clinigen’s managed access division following a physician request for individual patients who meet the established eligibility criteria.
Multiple myeloma is the second most common blood cancer. There are approximately 26,000 new cases of multiple myeloma in the US and 114,000 new cases globally per year. Although considered incurable, recent advancements in cancer research have meant that it is a treatable disease.
Simon Estcourt, managing director of managed access at the Clinigen Group, says: “Multiple myeloma is a devastating blood cancer with thousands of patients requiring treatment all over the world. As leaders in the specialist management of ethical access to innovative medicines, we will use our regulatory capabilities and global reach to support Takeda to provide early access for ixazomib – helping physicians to treat their patients with a current unmet medical need.”
Clinigen says it works to ethically source and supply unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need.
Lilian Anekwe
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