NorUDCA becomes first MASLD therapy approved in India
Form of fatty liver disease affects roughly 188 million people in country
India’s Central Drugs Standard Control Organization has approved the oral therapy nor-ursodeoxycholic acid (NorUDCA) for people with metabolic dysfunction-associated steatotic liver disease (MASLD), a form of fatty liver disease.
According to NorUDCA’s developer, Shilpa Medicare Limited, the approval makes NorUDCA the first MASLD treatment approved in India. The company said it plans to launch the therapy soon in India, where the disease is estimated to affect roughly 188 million people. NorUDCA will be available in 500 mg tablets. Shilpa also plans to pursue approvals in other countries.
“Receiving approval for NorUDCA marks a transformational leap — not only for Shilpa Medicare, but for millions silently suffering from liver disease,” Vishnukant Bhutada, managing director of Shilpa Medicare, said in a company press release. “We are excited to launch NorUDCA in India immediately and are actively pursuing approvals worldwide to ensure this vital therapy reaches patients everywhere in need.”
The approval follows a recommendation of approval from an Indian regulatory committee in March that was based on positive results from a Phase 3 clinical trial showing that the therapy reduced liver scarring, or fibrosis, and normalized a liver damage marker in MASLD patients.
NorUDCA is a modified version of a bile acid
MASLD, formerly known as non-alcoholic fatty liver disease (NAFLD), is marked by the buildup of fat in the liver in association with underlying metabolic conditions like diabetes or obesity.
Left unchecked, the buildup of liver fat in MASLD can lead to liver inflammation and fibrosis, setting the stage for life-threatening complications like liver failure and liver cancer. This damage to the liver can sometimes also cause cholestasis, when the flow of the digestive fluid bile from the liver to the intestines is slowed or stalled.
However, most people with MASLD won’t be diagnosed until irreversible damage has already occurred.
NorUDCA is a modified version of ursodeoxycholic acid or UDCA, a bile acid, or a main bile component, that is commonly used as a treatment for a number of liver diseases typically marked by cholestasis. Studies have indicated that NorUDCA can also improve bile flow, as well as reduce liver inflammation and fibrosis.
The therapy was previously shown to be generally safe and well tolerated in healthy volunteers within a Phase 1 clinical trial.
Application seeking approval followed positive Phase 3 trial results
Shilpa Medicare’s application seeking approval of NorUDCA in India followed positive results from a Phase 3 trial that tested NorUDCA, at a daily dose of 1,500 mg, against a placebo in 165 people with MASLD across India. Treatment was given for 24 weeks, or nearly six months.
According to the company, trial data met both of its main goals. Specifically, six months of NorUDCA treatment reversed liver fibrosis stage in 83.3% of participants and stabilized this stage in the remaining patients. The therapy also normalized the blood levels of alanine transaminase, a liver damage marker, in about 90% of participants within three months.
There were no reports of serious adverse events.
“We are honored to be the first company globally to bring this innovative therapy to patients, reflecting our unwavering commitment to pioneering healthcare solutions and expanding access to life-changing treatments across India and beyond,” Bhutada said.
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