Abbott Healthcare Gets CDSCO Panel Nod To Manufacture Market Ursodeoxycholic acid for Obstetric Cholestasis
New Delhi: Abbott Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Ursodeoxycholic acid tablets (IP 150 mg/300 mg/450 mg/600 mg tablet) for the treatment of obstetric cholestasis (intrahepatic cholestasis of pregnancy) with a condition that the firm should conduct a postmarketing surveillance (PMS) study.
In addition, the committee asked the firm to submit the PMS study protocol to CDSCO within 3 months from the date of approval of the drug for further evaluation.
This came after Abbott Healthcare presented the clinical study report before the committee.
Obstetric cholestasis (OC), also known as intrahepatic cholestasis of pregnancy (ICP), is a liver condition that can occur during pregnancy. The most common symptom is severe itching that can be all over the body, but is often worse on the hands and feet. Itching can be constant or recurrent, and is often worse at night. Other symptoms include dark urine, pale stools, tiredness, reduced appetite, and feeling sick.
Ursodeoxycholic acid (UDCA) is a secondary bile acid with cytoprotectant, immunomodulating, and choleretic effects. It reduces the cholesterol fraction of biliary lipids. UDCA inhibits the absorption of cholesterol in the intestine and the secretion of cholesterol into bile, decreasing biliary cholesterol saturation.
Ursodeoxycholic acid improves biliary flow, enhances the protective bicarbonate environment on the surface of cholangiocytes, and protects the liver from bile acid-induced apoptosis. This therapy has anti-inflammatory actions, and can reduce the elevation of serum bile acid concentration in the fetus, probably by upregulating placental bile acid export. As ursodeoxycholic acid is a bile acid, its use results in alteration of the bile acid pool so that it constitutes 60–70% of total bile acids in treated women and replaces more harmful (hydrophobic) bile acids.
At the recent SEC meeting for gastroenterology and hematology held on November 14, 2024, the expert panel reviewed the clinical study report of the drug ursodeoxycholic acid.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market ursodeoxycholic acid IP 300 mg/450 mg tablets as the firm has conducted the clinical study with 300 mg/450 mg tablets for the treatment of obstetric cholestasis (Intrahepatic Cholestasis of pregnancy) with the condition that the firm should conduct a postmarketing surveillance (PMS) study.
Accordingly, the expert panel stated that the firm should submit a PMS study protocol to CDSCO within 3 months from the date of approval of the drug for further review by the SEC Committee.
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