Maker withdraws semuloparin applications

Thrombus
Credit: Andre E.X. Brown

In the wake of a negative review by an FDA advisory panel, the makers of semuloparin have decided to pull all applications to market the drug.

On Monday, the European Medicines Agency (EMA) announced that Sanofi-Aventis had withdrawn its application for European marketing authorization, as well as all of its other applications worldwide.

Semuloparin is an ultra-low-molecular-weight heparin that was intended for use as thromboprophylaxis in cancer patients receiving chemotherapy for locally advanced or metastatic solid tumors.

In its letter to the EMA, Sanofi-Aventis said it decided to withdraw all applications for semuloparin sodium, 20 mg solution for injection, following comments by regulatory agencies.

The withdrawals do not prevent the company from submitting new applications later, however.

The application for European marketing authorization was submitted to the EMA in September 2011. At the time of withdrawal, the drug was under review by the EMA’s Committee for Medicinal Products for Human Use. The drug was also in late stages of review by the FDA.

The EMA has said it will soon provide more information about semuloparin and the state of the scientific assessment at the time of the application’s withdrawal.

This information, as well as the withdrawal letter, will be published on the EMA website after the Committee for Medicinal Products for Human Use meeting, which is taking place July 16-19.

Discussion

Notify me when a comment is posted for this article