Cadila Pharmaceuticals launches Obetocad, a generic Obeticholic Acid (Ocaliva®) in the liver therapy

Cadila Pharmaceuticals is amongst the first brands to launch generic Obeticholic Acid (Ocaliva®), in India. The molecule is used to treat Primary Biliary Cholangitis (PBC).

Ahmedabad: Cadila Pharmaceuticals launches Obetocad in India, a generic version of Ocaliva® (Obeticholic Acid) primarily used for the treatment of Primary Biliary Cholangitis (PBC).

For the treatment of PBC, currently Ursodeoxycholic acid (UDCA) is being extensively used. Around 40% of the patients do not respond to UDCA treatment and 5-10% of patients observe severe side effects. Obetocad can be used as a monotherapy or along with UDCA for treatment of patients who are unresponsive to UDCA therapy.

“There is an unmet need in the treatment of PBC. Ursodeoxycholic Acid is the only approved standard of care but a major chunk of the patients do not respond to the treatment. Obetocad containing Obetocholic Acid is now DCGI approved and shows positive results in patients. This generic drug is launched for the first time in the country, and with Obetocad, we hope to provide an option to all the patients of PBC” shared Mr. Narendra Deode, Vice President, Cadila Pharmaceuticals.

“With the launch of every product, we strengthen our core philosophy of providing quality medicines to all. With Obetocad, we plan to provide a quality solution to the patients of PBC who do not get relief from other standard therapy options. We are constantly working towards finding the next innovative drug for our patients” said Mr. O.P. Singh, President -Sales and Marketing, Cadila Pharmaceuticals Limited.

Obetocad is available in 5 mg and 10 mg tablets in packs of 10 tablets. It is also USFDA and EMA approved and recently received its DCGI approvals. Obetocad also has the potential to be used in other indications such as NASH, NAFLD, severe acute hepatitis, bile acid diarrhoea, bariatric and gallstone diseases.

Cadila Pharmaceuticals has always been focused on making sure high quality, affordable and life-saving treatments are within the reach of patients. Recently, Sepsivac® an innovative drug from Cadila Pharma received the pharma excellence award for being the most promising drug in the fight against COVID-19. Cadila Pharma has also recently launched 4 biosimilar products in the past 2 months under the brand name Bevaro™, Ritucad™, Cadalimab™ and NuPTH for treatment of cancer and osteoporosis. Cadila plans to launch multiple biosimilar products this year for the Indian Market.

Cadila Pharmaceuticals Ltd. (www.cadilapharma.com) is one of the largest privately-held pharmaceutical companies in India. It has recently concluded and cleared USFDA inspection successfully in February 2020. Over the past six decades, Cadila Pharmaceuticals has been engaged in the development and manufacturing of affordable medicines and in making them available for patients across the world. Its innovation-driven drug discovery processes ensure the health and well-being of people around the world.

References-

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• Nevens F. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis. N Engl J Med 2016;375:631-43.

• Hirschfield G M. Efficacy of Obeticholic Acid in patients with Primary biliary cirrhosis and inadequate response to ursodeoxycholic acid. Gastroenterology 2015;148:751-61

• Han, C.Y. Update on FXR Biology: Promising Therapeutic Target? Int. J. Mol. Sci. 2018, 19, 2069

• Bowlus C. Obeticholic acid for the treatment of primary biliary cholangitis in adult patients: clinical utility and patient selection. Hepat Med. 2016; 8: 89–95.