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Negative overtures persuade Sanofi to withdraw drug filing

Published on 10/07/12 at 12:20pm
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Sanofi's HQ in Paris

Sanofi has withdrawn its marketing applications worldwide for its drug Mulsevo.

Designed to stop blood clots in cancer patients receiving chemotherapy for locally-advanced or metastatic solid tumours, the injectable drug had been forecast by analysts to achieve annual sales of €240 million ($295 million).

The French firm says it has taken the decision on Mulsevo (semuloparin sodium) after negative opinions on its benefit/risk balance.

Documents from an FDA Oncologic Drugs Advisory Committee showed the expert panel were unimpressed by the reduction in blood clots achieved in the single trial in which the drug was studied. Concerns were also raised about serious bleeding events seen in patients taking the drug.

The oncologic drugs advisory committee voted 14 to 1 against Mulsevo on 20 June, a ruling which was clearly pivotal in Sanofi’s decision to abandon the drug.

The European regulator says more information about Mulsevo and its scientific assessment at the time of Sanofi’s withdrawal will be made public after a CHMP meeting next week.

Sanofi’s letter confirming its decision will also be made available then - but the EMA says a new application at a later stage would not be prejudiced.

A Sanofi spokesman the firm was evaluating the next steps for semuloparin, to determine 'the appropriate path forward,' but the withdrawal looks likely to spell the end for the molecule.

Adam Hill

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