Indian pharma company Dr. Reddy's Laboratories Ltd has announced the release of Elobixibat in the Indian market. The novel chronic constipation drug would be marketed under the brand name BixiBat.
The company's successful Phase-3 clinical trial submission to the CDSCO's Subject Expert Committee resulted in approval from the Central Drugs Standard Control Organisation. Dr. Reddy's is the first company to obtain approval and launch Elobixibat in the Indian market. “Elobixibat is a breakthrough drug approved for the treatment of chronic constipation. It acts by inhibiting the reabsorption of bile acids from ileum, thus increasing their concentration in the colonic lumen, leading to increased bowel movements due to stimulation of both colonic motility and fluid secretion irrespective of the transit speed”, the company said in a statement.
M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s, said: “The launch of this first-in-class drug is the latest in our continued efforts to bring novel molecules to patients in India. With over three decades of expertise and leadership in the gastrointestinal segment in India through trusted products such as Omez, Razo, Econorm, and Redotil, this latest offering will help us address unmet patient needs and further improve quality of life. The clinical studies for BixiBat have demonstrated significantly better and promising outcomes, making it a breakthrough drug in the management of chronic constipation and enhancing the current standard of care for its treatment in India”.
Research findings from Asia reveal that around 40% of chronic constipation patients remain unhappy with the prevailing treatment strategies. In India alone, an estimated 12% of the population suffers symptoms of constipation, with an increasingly worsening affect on quality of life.