Submit revised BE study protocol: CDSCO panel tells Laurus Labs on Carglumic Acid Dispersible Tablets
New Delhi: Rejecting drug maker Laurus Lab's proposal for clinical trial waiver of Carglumic acid dispersible tablets 200mg, the subject committee expert (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit a revised bioequivalence (BE) study protocol by capturing complete details such as the objective of the study, detailed clinical safety measures, protocol no., version, etc.
This came after the drug maker Laurus Lab presented its proposal for a grant of permission to manufacture and market Carglumic acid 200mg dispersible tablets with a clinical trial waiver in the country and presented the BE study protocol to conduct the BE study before the committee.
Carglumic acid is an analog of N-acetylglutamate (NAG) used for the treatment of acute and chronic hyperammonemia in patients with N-acetylglutamate synthase (NAGS) deficiency.
Carglumic acid is a drug used for the treatment of hyperammonemia in patients with a deficiency in N-acetyl glutamate synthase. This rare genetic disorder results in elevated blood levels of ammonia, which can eventually cross the blood–brain barrier and cause neurologic problems, cerebral edema, coma, and death. Carglumic acid was approved by the U.S. Food and Drug Administration (FDA) on March 18, 2010.
Carglumic acid is a synthetic structural analogue of N-acetylglutamate (NAG), which is an essential allosteric activator of the liver enzyme carbamoyl phosphate synthetase 1 (CPS1). CPS1 is found in the mitochondria and is the first enzyme of the urea cycle, which converts ammonia into urea. Carglumic acid acts as a replacement for NAG in NAGS deficiency patients by activating CPS1 but it does not help to regulate the urea cycle.
At the recent SEC meeting for endocrinology and metabolism held on February 16, 2023, the expert panel reviewed the BE study protocol and proposal presented by the drug major Laurus Labs to manufacture and market Carglumic acid 200mg dispersible tablets with a clinical trial waiver in the country.
After detailed deliberation, the committee recommended,
"The firm should submit a revised BE study protocol by capturing complete details as the objective of the study, detailed clinical safety measures, protocol no., version etc.Accordingly, the firm should submit a revised BE study protocol to CDSCO for further review by the committee."
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