Sanofi’s Plavix combination recommended for European approval
pharmafile | December 21, 2009 | News story | Research and Development, Sales and Marketing | DuoPlavin, Plavix, Sanofi, cabazitaxel, eplivanserin, idrabiotaparinux
Sanofi-Aventis has received the backing of a key European regulatory committee for its cardiology treatment DuoPlavin, which combines its blockbuster Plavix with aspirin.
The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended the drug, which treats patients with acute coronary syndrome (ACS), should be granted marketing authorisation.
The brand is seeking an indication to prevent atherothrombotic events in adult ACS patients who are already taking Plavix (clopidogrel) and aspirin (acetylsalicylic acid).
DuoPlavin is a new fixed combination of both drugs, thus simplifying the treatment.
The news will be a relief to Sanofi, as last year the company and long-time partner Bristol-Myers Squibb withdrew their European marketing submission in order to conduct a bioequivalence study in line with data requests from European regulators.
Sanofi’s pipeline
Elsewhere in Sanofi’s pipeline, oncology treatment cabazitaxel has been fast-tracked by the US Food and Drug Administration.
The FDA will allow Sanofi to make a rolling submission for a New Drug Application (NDA) in second-line prostate cancer for the drug.
The process, which has already started, means that completed sections of an NDA can be submitted on an ongoing basis.
In the phase III TROPIC study, the primary endpoint of overall survival with cabazitaxel achieved statistical significance, Sanofi says.
Results will be presented next March at the American Society of Clinical Oncology – Genito-Urinary cancers congress.
The company says discussions with the EMA regarding a European submission for cabazitaxel are “ongoing”.
But Sanofi’s R&D pipeline has also suffered two blows, with unfavourable results and changes in market conditions leading it to shelve drugs for insomnia and thrombosis.
The submission dossier for eplivanserin, which was being developed to help insomniacs, is to be withdrawn in the US and Europe following a complete response letter issued by the FDA in September.
Sanofi says the decision has been taken “considering the needs for significant further clinical developments and market access constraints”.
The company has also stopped development of idrabiotaparinux for the prevention of thromboembolic events in patients with atrial fibrillation.
“Considering recent therapeutic advances in this field, this compound does not appear able to bring significant improvement in the care of these patients,” Sanofi said.
The company has recently announced that its site in Dagenham – which produced cancer drugs Taxotere (docetaxel) and Eloxatin (oxaliplatin) among others – is to close by the end of 2013, with manufacturing work set to transfer to Frankfurt.
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