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Review
. 2018 Oct;78(15):1639-1642.
doi: 10.1007/s40265-018-0989-0.

Caplacizumab: First Global Approval

Sean Duggan  1
Affiliations
Review

Caplacizumab: First Global Approval

Sean Duggan. Drugs. 2018 Oct.

Erratum in

Abstract

Ablynx, a Sanofi Company, has developed the anti-von Willebrand factor Nanobody® caplacizumab (Cablivi™) for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP). Based on positive results in phase II and III trials in patients with aTTP, caplacizumab was recently approved in the EU for the treatment of adults experiencing an episode of aTTP, in conjunction with plasma exchange and immunosuppression. This article summarizes the milestones in the development of caplacizumab leading to this first approval.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Sean Duggan is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Figures

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Key milestones in the development of caplacizumab, leading to its first global approval in acquired thrombotic thrombocytopenic purpura
See this image and copyright information in PMC

References

    1. European Medicines Agency. Cablivi (caplacizumab): summary of product characteristics. 2018. http://www.ema.europa.eu. Accessed 7 Sept 2018.
    1. Sanofi. Cablivi™ (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura (aTTP) [media release]. http://www.news.sanofi.us/. Accessed 3 Sept 2018.
    1. European Medicines Agency. Cablivi (caplacizumab): EU assessment report. 2018. http://www.ema.europa.eu/ema/. Accessed 13 Jun 2018.
    1. Joly BS, Coppo P, Veyradier A. Thrombotic thrombocytopenic purpura. Blood. 2017;129(21):2836–2846. doi: 10.1182/blood-2016-10-709857. - DOI - PubMed
    1. Ablynx. Understanding nanobodies. 2018. http://www.ablynx.com/technology-innovation/understanding-nanobodies/. Accessed 14 Sept 2018.

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