Zydus receives marketing authorization for RabiMabs from Drug Controller General of India

03 Sep 2019 Evaluate

Zydus has received marketing authorization for Twinrab (RabiMabs) from the Drug Controller General of India. The novel biologic which will be marketed under the brand name, Twinrab, is indicated in combination with rabies vaccine for rabies post-exposure prophylaxis. The United States Food and Drug Administration (USFDA) has granted an orphan drug status to this candidate.

In 2008, Zydus had entered into an agreement with the World Health Organization (WHO) to explore opportunities in the development of a cocktail of monoclonal antibodies for the treatment of rabies. The use of rabies monoclonal antibodies could emerge as an innovative therapy and form a potent alternative to current blood derived rabies immunoglobulins (RIG’s) produced by vaccinating horses (ERIG) or humans (HRlG).

WHO encourages the use of monoclonal antibodies over blood derived RIG where available and has identified the development of products containing two or more antibodies that bind to two different sites on the rabies virus as a research priority. Zydus’ Twinrab is the only therapy that meets this requirement.
The company currently also manufactures and markets the rabies vaccine - VaxiRab NTM which is a WHO pre - qualified vaccine.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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