BRIEF — Takeda delayed in Ninlaro label expansion bid

5 February 2019

Japanese drugmaker Takeda has withdrawn the US filing that asked for a further indication with its multiple myeloma drug Ninlaro (ixazomib).

Within the detail of the company’s latest financial results was news that the company has withdrawn the application to expand Ninlaro’s use as a maintenance therapy in post-transplant patients.

Discussions with the US Food and Drug Administration showed that the regulator wants data on how long Ninlaro can extend patients’ lives, evidence that Takeda does not currently have.

Shares in Takeda were 3% down on Tuesday.

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