Laurus Lab Gets CDSCO Panel Nod To Manufacture and Market Sodium Phenylbutyrate Powder

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-05-22 12:30 GMT | Update On 2024-05-22 12:30 GMT

New Delhi: Noting that urea cycle disorder is a very rare disease and there are unmet medical needs in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to Laurus Lab to manufacture and market Sodium Phenylbutyrate powder.

However, this approval is subject to the condition that the firm should conduct a Phase IV clinical trial for which Phase IV clinical trial protocol is to be submitted to CDSCO within 3 months.

This came after Laurus Labs presented its bioequivalence (BE) study report for a grant of permission to manufacture and market Sodium Phenylbutyrate powder.

The committee noted that Urea Cycle Disorder is a very rare disease and there is unmet medical need in the country. The committee also noted that the drug is already approved in the US, Europe, and Canada.

Sodium phenylbutyrate is used together with a proper diet to help treat urea cycle disorders, including carbamyl phosphate synthetase deficiency (CPS), ornithine transcarbamylase deficiency (OTC), or argininosuccinate synthetase (AS).

Sodium phenylbutyrate metabolites allow the kidneys to excrete excess nitrogen in place of urea and coupled with dialysis, amino acid supplements, and a protein-restricted diet, children born with urea cycle disorders can usually survive beyond 12 months. Patients may need treatment for all their life.

At the recent SEC meeting for the endocrinology and metabolism held on 16th May 2024, the expert panel reviewed the BE study report of Sodium Phenylbutyrate powder presented by Laurus Labs.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the applied drug for proposed indication subject to the condition that the firm shall conduct a Phase IV clinical trial for which Phase IV CT protocol is to be submitted to CDSCO within 3 months of approval for further evaluation by the committee.

Also Read:CDSCO Panel grants Novartis Protocol Amendment Proposal to study Remibrutinib in Chronic Spontaneous Urticaria

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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Laurus Lab Gets CDSCO Panel Nod To Manufacture and Market Sodium Phenylbutyrate Powder

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