Fast acting anti-rabies drug set for an India launch

An instantly activated drug, in other words a fast acting anti-rabies drug to rapidly deactivate the rabies virus is soon to be launched in India. It will provide an immediate protection in severe dog bite cases.

This rabies human monoclonal antibody (RMAb), has been developed by Pune-based Serum Institute of India (SII) and US-based Mass Biologics of the University of Massachusetts Medical School.

Likely to be launched this year, the drug is a safe and effective method to control rabies, as found evident during its clinical trial phase of nine years in India and abroad.

This is a significant advancement in rapid vaccination of rabies, with the existing protection taking 14 days to produce antibodies. It becomes a critical situation as the virus can reach the brain within 14 days if a dog bite is severe or closer to the head.

The World Health Organisation (WHO) has put India in the high risk of deaths estimated to occur every year, along with rural areas of Africa and Asia. In India alone, 20,000 deaths (about two per one-lakh population at risk) are estimated to occur every year.

"Our new drug - Rabishield - is a first-of-its-kind rabies human monoclonal antibody in the world and has been developed in a laboratory set up. It automatically precludes chances of transmitting blood-borne infections that are present in rabies immunoglobulin, the current line of treatment for severe dog bite cases," Adar Poonawalla, the chief executive officer of SII, told TOI.

The drug has been manufactured using recombinant DNA technology. "We have completed the scale-up of the manufacturing process as well as the clinical development of Rabishield. The drug will have its global launch in India this year. Since the new drug will be 25% cheaper than the existing rabies immunoglobulins, it would meet the needs of the poor countries," Poonawalla said.

"The potential risk of contamination with blood borne pathogens is avoided and skin hypersensitivity testing is not required while using Rabishield," Poonawalla said.

SII executive director Rajeev Dhere has in addition implied that this fast acting fast-acting rabies human monoclonal antibody, when used in combination with the rabies vaccine, makes the whole treatment more cost effective.

As reported by TOI, the new drug is a human IgG1 monoclonal antibody that specifically binds to a conformational epitope of G glycoprotein of rabies virus and instantly deactivates it. "This is a first of its kind recombinant human monoclonal antibody for rabies prophylaxis in the world," Dhere said.

Why the monoclonal antibody?

Human rabies immune globulin (hRIG), derived from human blood, is an expensive product and carries a potential risk of contamination with blood-borne pathogens. Equine immune globulin (eRIG), derived from horse serum, is used in many parts of the world but its use is associated with significant adverse effects such as anaphylaxis or serum sickness.