India's Serum Institute chases fast-track approval for dengue treatment as cases spike
- Dengue is a debilitating tropical viral disease that affects more than 100 countries and kills at least 22,000 people per year. It is spread by mosquitos and there is currently no treatment. New Delhi is facing the worst outbreak of dengue fever in five years.
- Serum Insitute of India is Asia's largest vaccine maker and is currently chasing fast-track approval for a dengue medication.
- Serum bought exclusive rights from U.S. biotech Visterra to sell its monoclonal antibody, VIS513, as a treatment for dengue. The deal is said to be worth up to $39 million.
Dengue fever represents a serious unmet medical need in India and other places around the world. In India, the number of cases has been steadily rising in the last several years, and because there is no treatment, patients are consigned to palliative care—rest, fluids, and paracetamol.
Serum Institute researchers are hoping to gain approval in a year or less, although so far the antibody has only been tested in animals. Based on preclinical data, researchers anticiapate that a human who received an injection of VIS513 would experience improvement within three to four days.
At the same time that Serum Insitute is moving forward with a treatment, Sanofi is hard at work on a dengue vaccine, and things are progressing rapidly on that front.
The most recent data published in the New England Journal of Medicine (NEJM) focuses on interim data from a four-year, long-term study. Researchers found that protection against dengue reached 93% and prevention of hospitalizations due to dengue reached 80% in volunteers starting at age nine and all the way through various stages of adulthood.