Licence change approved in EU .
CHMP issues a positive opinion for an extension to the existing indication to include treatment of adolescents. The new indication will be treatment of adults and adolescents of 12 years of age and older weighing at least 40 kg experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression .
Launched in the UK. Price 1 pack=£4143.00 
Approved in US .
Sanofi does plan to launch Cablivi in the UK but launch plans unclear. Cablivi has been selected for NICE technology appraisal so launch may be delayed until the outcome of this is known .
Has been filed in US .
Launched in Germany by Sanofi-Genzyme 
Approved in the EU. Caplacizumab (Cablivi) is the first therapeutic specifically indicated for the treatment of aTTP. Also filed in the US with priority review designation with a target action date Feb 2019 .
US filing planned for acquired TTP .
Recommended for EU approval by CHMP - the full indication is "for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression." It is proposed that caplacizumab be prescribed and supervised by physicians experienced in the treatment of management of patients with thrombotic microangiopathies .
CHMP extends earlier clock-stop from June 17 related to Day 120 List of Questions, as the company still wished for time to respond to outstanding issues .
Awarded Fast Track Designation by US FDA .
Ablynx have submitted a Marketing Authorisation Application (MAA) to the EMA for caplacizumab, its first-in-class anti-von Willebrand factor (vWF) Nanobody® for acquired thrombotic thrombocytopenic purpura .
Ablynx reported that it intends to seek conditional approval from the EMA for caplacizumab in the treatment of acquired thrombotic thrombocytopenic purpura in the first half of 2017; product launch is anticipated in 2018 .