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Lupin gets USFDA nod for Obeticholic Acid tablets
(15:46, 31 May 2023)
Obeticholic acid is used alone or in combination with ursodiol (Actigall, Urso) to treat primary biliary cholangitis (PBC; a type of liver disease that destroys bile ducts, which allows bile to stay in the liver and cause damage). Obeticholic acid is in a class of medications called farnesoid X receptor agonists. It works by decreasing the production of bile in the liver and increasing the removal of bile from the liver.

Ths said drug is generic equivalent to Ocaliva Tablets of Intercept Pharmaceuticals. This product will be manufactured at Lupin's Nagpur facility in India.

According to IQVIA MAT March 2023, Obeticholic Acid Tablets had estimated annual sales of $262 million in the U.S.

Separately, the company announced a strategic collaboration with Enzene Biosciences to launch Cetuximab in India, the first biosimilar developed for Cetuximab. This collaboration marks a significant milestone in expanding therapeutic options and fostering innovation in the critical area of treatment of head and neck cancer.

The disease is often diagnosed at advanced stages, making effective treatment increasingly challenging. As a result, head and neck cancer carries a substantial burden, leading to significant difficulties in providing effective treatment and resulting in high mortality rates.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company reported consolidated net profit of Rs 235.96 crore in Q4 FY23 as compared with net loss of Rs 517.98 crore in Q4 FY22. Net sales jumped 12.1% to Rs 4,330.30 crore in Q4 FY23 as against Rs 3,864.50 crore in Q4 FY22.

The scrip had advanced 0.19% to Rs 805.20 on the BSE

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