BiznextIndia : Zydus on Tuesday announced that it has received marketing authorization for TwinrabTM (RabiMabs) from the Drug Controller General of India. The novel biologic which will be marketed under the brand name, TwinrabTM, 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 ofrabies. The use ofrabies 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’ TwinrabTM is the only therapy that meets this requirement