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CHMP recommends approval of Sanofi’s Cablivi

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Cablivi (caplacizumab) in Europe for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder, which can be made available to patients through Sanofi Genzyme.

Cablivi, by Ablynx, a Sanofi Company, will be reviewed by the European Commission, who is expected to have a final decision on the Marketing Authorisation Application in the European Union in the coming months, Sanofi said in the Friday press release.

The drugmaker further noted that, directed against von Willebrand Factor (vWF), Cablivi is Ablynx’s first Nanobody-based medicine to receive a positive CHMP opinion and, if approved, will be the first therapeutic specifically indicated for the treatment of aTTP.

No products currently authorised for the treatment of aTTP 

aTTP is a life-threatening, autoimmune-based blood clotting disorder characterized by extensive clot formation in small blood vessels throughout the body, leading to thrombocytopenia, ischemia and widespread organ damage especially in the brain and heart, it was explained in the statement. The company also pointed out that there are currently no products authorised for the treatment of aTTP and despite treatment with plasma exchange (PEX) and immunosuppression, patients remain at risk for thrombotic complications, recurrences and death. Sanofi noted that the potential of Cablivi to address this unmet need has been demonstrated in 220 patients with aTTP, who participated in the phase II TITAN and phase III HERCULES studies.

As said by the French drugmaker, data from the TITAN study were published in the New England Journal of Medicine in February 2016 and the positive HERCULES results were presented at the 59th Annual Meeting of the American Society of Hematology (ASH) in December 2017.

Sanofi added that, if approved, Cablivi will be part of the Genzyme’s new rare blood disorders franchise that will launch in 2019 and which will also include Bioverativ’s treatments for Hemophilia A and B.

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