Emicizumab (trade name Hemlibra) is a humanized bispecific antibody for the treatment of haemophilia A, developed by

Genentech Genentech, Inc., is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within R ...

and

Chugai is a drug manufacturer operating in Japan. It is a subsidiary controlled by Hoffmann-La Roche, which owns 62% of the company as of 30 June 2014. The company is headquartered in Tokyo. Osamu Nagayama is the current representative director and ...

(a subsidiary of Roche). A Phase I clinical trial found that it was well tolerated by healthy subjects. In November 2017, it was approved in the United States for treatment of haemophilia A in those who had developed resistance to other treatments. It was subsequently approved by the US FDA in April 2018 under the

breakthrough therapy designation Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "br ...

for treatment of haemophila A in those who have ''not'' developed resistance to other treatments. The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.

Mechanism of action

Emicizumab binds to both the activated coagulation factor IX and to factor X, mediating the activation of the latter. This is normally the function of coagulation factor VIII, which is missing in haemophilia A patients.

References

External links

* Breakthrough therapy Haemophilia Hoffmann-La Roche brands Genentech brands Monoclonal antibodies {{blood-drug-stub