- The European Medicines Agency on Friday recommended rejection for Takeda's application to sell its multiple myeloma drug Ninlaro in the E.U. Takeda indicated it would appeal the decision and request a re-examination.
- In its statement on the decision, the EMA's drug committee said the evidence Takeda presented from its principal clinical study was insufficient to support approval.
- The rejection is a setback for Takeda, which won approval for Ninlaro in the U.S. last year. Competing multiple myeloma drugs from Amgen and Bristol-Myers Squibb are already approved in the E.U.
Takeda expressed disappointment in the EMA's decision, pointing to a need for further treatment options for European patients suffering from multiple myeloma.
The company had applied for second-line approval for Ninlaro, meaning the drug would be used for patients who had received at least one prior treatment. But the EMA did not find Takeda's evidence compelling, even for this limited use.
"The data in these subgroups were not compelling enough and the rationale for assuming greater effectiveness in these patients was not clear," the EMA said.
Takeda did get some good news on Friday, however. The EMA approved a broader indication for the Japanese drugmaker's cancer drug Adcertis, allowing its use for treatment of adults with a certain type of Hodgkin's lymphoma who are at increased risk of relapse after stem cell transplantation.