Takeda Submits NDA for Ixazomib for Myeloma
Takeda Pharmaceutical Company Limited has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for ixazomib, an investigational oral proteasome inhibitor for treating relapsed and/or refractory multiple myeloma. This is the first regulatory submission for ixazomib. Additional filings are planned to begin in Europe and other countries later this year, according to Takeda.
Ixazomib was granted orphan drug designation in multiple myeloma in the United States and Europe in 2011 and for immunoglobulin light chain (AL) amyloidosis in the US and Europe in 2012. Ixazomib received breakthrough therapy status by the FDA for relapsed or refractory AL amyloidosis in 2014. Amyloidosis is caused by the buildup of an abnormal protein called amyloid. Amyloid is produced in the bone marrow and can be deposited in any tissue or organ. AL amyloidosis, the most common type, can affect the heart, kidneys, skin, nerves and liver. It was previously known as primary amyloidosis. It occurs when the bone marrow produces abnormal antibodies that can’t be broken down. The antibodies are deposited in tissues as amyloid, interfering with normal function.
Source: Takeda Pharmaeutical