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

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.