Ablynx submits a marketing authorisation application to the European Medicines Agency for caplacizumab

February 6, 2017 News BioVox

In the Phase II TITAN study, treatment with caplacizumab significantly reduced the time to platelet count normalisation and the number of recurrences of aTTP while on drug treatment. Post-hoc analysis of the TITAN study demonstrated that caplacizumab dramatically reduced the number of patients experiencing major thromboembolic events while on drug treatment. Ablynx is on track to report results of the confirmatory Phase III HERCULES study in the second half of 2017 and these results are expected to support a BLA filing in the United States in 2018. Ablynx intends to lead the commercialisation of caplacizumab in Europe and North America.

Ablynx announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for approval of caplacizumab, its anti-von Willebrand factor (vWF) Nanobody® for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP), an ultra-rare, acute, life-threatening blood clotting disorder with a high unmet medical need.

The MAA includes data from the Phase II TITAN study in patients with aTTP which demonstrated a statistically significant and clinically meaningful benefit of caplacizumab treatment in reducing the time to platelet count normalisation and reducing recurrences while on drug treatment. Results of post-hoc analyses of the Phase II TITAN study further demonstrated that caplacizumab dramatically reduced the number of patients experiencing major thromboembolic events, as compared to placebo.

If approved, caplacizumab will be the first therapeutic specifically indicated for the treatment of aTTP.

Dr Edwin Moses, CEO of Ablynx, commented:
“As pioneers in the treatment of aTTP, we are committed to making caplacizumab available to patients suffering from this severe disease for which there is currently no specifically approved drug available. This is a very important moment in the development of Ablynx, as we prepare to commercialise our first product and become a fully vertically integrated biopharmaceutical company. We look forward to working with the EMA during this review process.”


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