Sanofi discontinues insomnia, thrombosis drugs

Sanofi-Aventis has issued a mini-update of its R&D pipeline this morning which reveals that development on two products has been terminated.

The first of the projects to be pulled is the investigational insomnia treatment, eplivanserin. In September the US Food and Drug Administration issued a complete response letter requesting additional information “regarding benefit-risk” of the serotonin type 2 A receptor antagonist which had been studied in a clinical programme including nearly 3,000 patients.

The French drugmaker had high hopes for the product given that unlike current hypnotics, eplivanserin is not a sedative and therefore had no after-effects the following morning. However Sanofi says that “considering the needs for significant further clinical developments and market access constraints”, the eplivanserin submission dossier in insomnia will be withdrawn in the USA and in Europe.

The company also noted that idrabiotaparinux has been discontinued as a potential treatment for the prevention of thromboembolic events in patients with atrial fibrillation. Sanofi said that “considering recent therapeutic advances in this field, this compound does not appear able to bring significant improvement in the care of these patients”.

On a positive note, the FDA has granted a fast track designation allowing a rolling submission of a New Drug Application for Sanofi’s cabazitaxel in second-line prostate cancer. The primary endpoint of a Phase III study, which was overall survival, met statistical significance and full will be presented in March.

The company also revealed “ongoing discussions” with the European Medicines Agency regarding submission for cabazitaxel.