Ablynx has applied its caplacizumab to European Medicines Agency for approval to use it for a form of blood clotting disorder.
EMA will consider Ablynx’s Willebrand factor Nanobdoy based on a phase two study in which acquired thrombotic thrombocytopenic purpura (aTTP) patients saw improvements after being treated with Ablynx’s caplacizumab. The study showed that the antibody reduced the number of patients with major thromboembolic events compared to placebo.
Ablynx pointed out that, if approved, caplacizumab will be the first therapeutic specifically indicated for the treatment of aTTP.
Dr Edwin Moses, CEO of Ablynx, said: “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.”