European Commission authorises first-ever rare blood condition drug

pharmafile | September 4, 2018 | News story | Manufacturing and Production, Sales and Marketing Europe, Sanofi, approvals, cablivi, eu commission 

Sanofi have announced that the European Commission granted marketing authorisation for Cablivi (caplacizumab) for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopaenic purpura (aTTP). The approval marks the first therapeutic specifically indicated for the disease.

“The approval of Cablivi provides new hope for people diagnosed with aTTP, who to date have faced a very difficult disease with limited treatment options,” stated Bill Sibold, who heads Sanofi Genzyme.

The French pharma giant Sanofi acquired the rights for the drug through the acquisition of Ablynx for €3.9 billion, earlier this year.

Advertisement

The authorisation was based on the Phase II TITAN trial and the Phase III HERCULES trial which demonstrated that cablivi was associated with a 74% reduction in the percentage of patients experiencing an aTTP related death.

According to Sanofi there are approximately 7,500 patients with aTTP symptoms in the United States, the European Union and Japan. The FDA, which has granted a fast track designation for the treatment of aTTPis now expected to come to a decisionby February 6th 2019.

Louis Goss

Related Content

Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria

Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …

Sanofi’s treatment granted orphan designation for rare chronic inflammatory condition

The European Medicines Agency has granted orphan designation to Sanofi’s investigational Bruton’s tyrosine kinase (BTK) …

sanofi

Sanofi completes acquisition of Vigil Neuroscience to early neurology pipeline

Sanofi has announced that it has finalised its acquisition of Vigil Neuroscience, a US-based biotechnology …

The Gateway to Local Adoption Series

Latest content