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Sanofi withdraws all applications for Mulsevo in prevention of blood clots

Follows negative vote from FDA panel

Sanofi has pulled all applications to market Mulsevo for the prevention of blood clots in cancer patients a month after reviewers from the US Food and Drug Administration (FDA) said data was insufficient to support approval.

European regulator the European Medicines Agency (EMA) said the French pharma firm had decided to pull all global submissions for the drug's use in primary prevention of venous thromboembolism (VTE) in people receiving chemotherapy for locally-advanced or metastatic solid tumours following “comments by regulatory agencies”.

Sanofi had initially submitted its application to the EMA for the injectable Mulsevo (semuloparin sodium) in September, 2011, in the hope of countering the patent expirations of several of its key products over the next two years.

However, the drug's regulatory journey has been troubled, and just last month an advisory panel to the FDA voted 14 to one, with one abstention, that current data did not sufficiently demonstrate a positive benefit-to-risk profile for the product's use in a similar indication.

Panel members highlighted Sanofi's lack of clarity in defining which patients would benefit most from Musevo, and raised concerns about incidents of bleeding during clinical trials.

In a statement, Sanofi confirmed it was this panel vote that influenced its decision to withdraw all global applications, with the company deciding to pull submissions early rather than face a rejection further down the line.

Speaking to Bloomberg, Alistair Campbell, an analyst at Berenberg Bank in London, commented on Sanofi's decision to pull all regulatory filings.

He said: “In the grand scheme of things, in terms of potential sales lost, it's not a massive change. It's more of a sentiment setback. It's a blow to a late-stage pipeline already seen as weaker [than other pharma companies]. Questions will remain about Sanofi's drug pipeline.”

Analysts had previously forecast annual global peak sales for Mulsevo of €550m ($677m) by 2017, according to Reuters.

10th July 2012

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