The U.S. Food and Drug Administration (FDA) has granted a Priority Review status to the New Drug Application for ixazomib, an oral inhibitor for the treatment of patients with multiple myeloma. The confirmation about the priority status came from the manufacturer of the drug, Takeda Pharmaceutical Company Limited.
Ixazomib is the first investigational oral proteasome inhibitor for the patients with relapsed or refractory multiple myeloma. It is also meant for the patients who suffer from the combination of the conditions.
“We are encouraged that both the U.S. and European regulatory bodies have determined that the ixazomib applications qualify for an expedited review, underscoring the importance of new treatment options for patients with relapsed/refractory multiple myeloma,” said Melody Brown, the vice president of Regulatory Affairs at Takeda, in a press release.
Brown further revealed that the ixazomib program by Takeda is designed to see whether the sustained therapy with oral inhibitor proves successful in treating people with multiple myeloma. Takeda believes that there are a number of medical needs that are still unmet in the case of people with multiple myeloma, and the company is hopeful to bring ixazomib to patients, with the help of the regulatory bodies.
The Priority Review status by FDA ensures a speedy review and evaluation of the drug applications that are received by the regulatory body. Such applications are regarding the drugs that are used to treat serious conditions. The approval of the application results in a “significant improvement in safety or efficacy over existing treatment.”
Multiple myeloma is a cancer of the plasma cells. It is estimated that nearly 114,000 cases of the disease are reported globally in a year, including 20,000 alone in the U.S.