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TOKYO, March 12 (Reuters) - U.S. regulators have rejected Daiichi Sankyo Co Ltd’s (4568.T) injectable anaemia drug Injectafer for the broad treatment of uterine bleeding and in a surprise move also knocked it back for a narrower use.
The Japanese drug maker, which licensed rights to the drug from Swiss healthcare provider Galenica GALN.S, said it had received a “non-approvable” letter from the U.S. Food and Drug Administration.
An advisory panel to the FDA had voted in February against recommending broad use of the drug but said the benefits outweighed the risks for women who could not tolerate oral iron or had an unsatisfactory response to it.
Galenica shares soared last month after it appeared likely to receive approval for the narrower indication.
The FDA is not bound by the panel’s recommendations but takes the advice into consideration.
The FDA asked for additional trials and safety data and Daiichi Sankyo said in a statement it would continue to develop the drug. (Reporting by Aiko Hayashi, editing by Edwina Gibbs)