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Sanofi withdraws Mulsevo application in EU

PARIS (Reuters) - Sanofi has withdrawn its application to sell Mulsevo, an experimental drug to prevent blood clots in chemotherapy patients, in the European Union after it failed to win the backing of the U.S. regulator last month, the European Medicines Agency said on Monday.
/ Source: Reuters

PARIS (Reuters) - Sanofi has withdrawn its application to sell Mulsevo, an experimental drug to prevent blood clots in chemotherapy patients, in the European Union after it failed to win the backing of the U.S. regulator last month, the European Medicines Agency said on Monday.

Sanofi said in its withdrawal letter that it decided to withdraw all applications globally following comments by regulatory agencies, according to an EMA statement.

A Sanofi spokeswoman confirmed the company had withdrawn the application but declined further comment.

A Food and Drug Administration panel last month voted 14 to 1 saying the company had not done a good job of defining exactly which patients would benefit most from the injectable drug, which is known generically as semuloparin.

Mulsevo is one of several experimental drugs Sanofi has filed with regulators as it seeks to generate growth from new treatments after the loss of top-selling medicines to generic rivals.

The drug was expected to generate annual sales of around 550 million euros ($677 million) by 2018 if approved, according to analysts.

Sanofi shares, which have gained around 6 percent since the start of 2012, were trading 0.8 percent higher at 60.22 euros at 1402 GMT, outperforming the French blue-chip CAC 40 index, down 0.5 percent.

($1 = 0.8126 euros)

(Reporting by Elena Berton; Editing by James Regan)