Submit additional data: CDSCO Tells Laurus Labs to on Carglumic acid dispersible tablets
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug major Laurus Labs conduct the bioequivalence (BE) study of Carglumic acid 200mg dispersible tablets and submit the additional report along with additional data with respect to the orphan drug status in the United States and Europe and published clinical trial data.
This came after Laurus Labs presented the revised bioequivalence study protocol along with a Phase III clinical trial waiver in the country for the grant of permission to manufacture and market the Carglumic acid 200mg dispersible tablets before the committee.
Carglumic acid is used to treat the severe hyperammonemia that occurs in the urea cycle disorder caused by a deficiency of hepatic N-acetyl glutamate synthase (NAGS) which normally produces N-acetyl glutamate. Hyperammonemia is a metabolic condition characterized by raised levels of ammonia, a nitrogen-containing compound.
Carglumic acid is an analog of N-acetyl glutamate (NAG) used to treat acute and chronic hyperammonemia in patients with N-acetyl glutamate synthase (NAGS) deficiency.
Carglumic acid is a synthetic structural analog of N-acetyl glutamate (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 urea cycle enzyme, 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 15th and 16th June 2023, the expert panel reviewed the revised bioequivalence study protocol of Carglumic acid 200mg dispersible tablets.
After detailed deliberation, the committee recommended conducting the BE study and submitting the report along with the additional data with respect to the orphan drug status in US and Europe and published clinical trial data for further consideration.
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