Laurus Labs gets CDSCO panel nod to conduct BE study of cystic fibrosis FDC drug
New Delhi: The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has granted permission to Laurus Labs to conduct the bioequivalence (BE) study of Fixed Dose Combination (FDC) drug, Lumacaftor and Ivacaftor tablet 100/125 & 200/125 mg.
In addition, the committee opined that the approval of the drug could be considered based on the results of the BE study, subject to the condition that the firm conduct active post-marketing surveillance.
This recommendation came after the Laurus Lab presented their proposal for conducting a bioequivalence study (BE) along with justification for a local clinical trial waiver before the committee.
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent, it means that they would be expected to be, for all intents and purposes, the same.
Ivacaftor and lumacaftor are orally available potentiators or correctors of the cystic fibrosis transmembrane conductance regulator (CFTR) that are used to treat patients with cystic fibrosis with specific mutations of the CFTR.
Cystic fibrosis is an autosomal recessive disease caused by one of numerous mutations in the CFTR gene, which codes for a transmembrane ion channel that transports chloride and sodium ions across cell membranes in the lungs, pancreas, and other organs.
Mutations in the CFTR gene cause improper fluid and ion transport across cell membranes due to altered synthesis, misfolding, or function of the CFTR protein.
As a result, CF patients produce thick, sticky mucus that clogs organ channels, making them more vulnerable to infections, lung damage, pancreatic insufficiency, and malnutrition.
Lumacaftor improves Cystic fibrosis (CF) symptoms and underlying disease pathology by aiding the conformational stability of F508del-mutated CFTR proteins, preventing misfolding and resulting in increased processing and trafficking of mature protein to the cell surface.
The medicine ivacaftor is used to treat Cystic Fibrosis (CF). Vertex Pharmaceuticals manufactures and distributes it. The Food and Drug Administration authorised it on January 31, 201213, and Health Canada approved it in late 2012. Ivacaftor is used to treat CF patients as a monotherapy as well as in combination with other medications.
The SEC committee in its 53rd meeting for pulmonary held on August 31, 2021 at CDSCO, reviewed the proposal presented by Laurus Lab for conducting a bioequivalence study (BE) of the fixed dose combination drug, Lumacaftor and Ivacaftor tablet 100/125 & 200/125 mg, along with justification for local clinical trial waiver before the committee.
The committee noted that the drug is proposed to be indicated for rare, life-threatening diseases and that there is an unmet medical need for the drug in the country.
Further, the committee observed that the drug is approved by the USFDA, Canada, and Europe.
After detailed deliberation, the committee recommended the grant of permission to conduct the BE study as per the protocol presented, and the results of the BE study should be presented before the committee.
The committee also recommended that approval of the drug be considered based on the results of the BE study, subject to the condition that the firm conduct active post-marketing surveillance for which protocol should be submitted to CDSCO within three months of approval of the drug.
