Exemed Pharmaceuticals gets CDSCO Panel nod to study Sacubitril plus Valsartan film-coated sustained release tablet

New Delhi: Reviewing the justification for the variability of the kinetic data of the bioequivalence (BE) study report of the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus Valsartan film-coated sustained-release tablet presented, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Exemed Pharmaceutical to conduct the BE study under Fed condition.

This came after the firm presented the proposal along with justification for the variability of the kinetic data of the BE study report along with the BE study protocol under Fed conditions and Phase III clinical trials protocol before the committee.

Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalization. This medicine is also used to treat children with symptomatic heart failure. Valsartan is an angiotensin II receptor blocker (ARB).

Sacubitril blocks the breakdown of natriuretic peptides produced in the body. Natriuretic peptides cause sodium and water to pass into the urine, thereby reducing the strain on the heart. They also reduce blood pressure and protect the heart from developing fibrosis (scar tissue) that occurs in heart failure.

Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. Valsartan relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.

At the recent SEC meeting for Cardiovascular held on 17th September 2024, the expert panel reviewed the justification for variability of the kinetic data of the BE study report along with the BE study protocol under Fed condition and Phase III CT protocol presented by the drug major Exemed Pharmaceutical.

After detailed deliberation, the committee considered the BE study report under fasting conditions and recommended conducting a BE study under Fed conditions.

As regard the Phase III CT study, the committee recommended conducting the study with the following conditions:

1. A patient with a plasma level of NT-pro BNP should be more than 120pg/mL in inclusion criteria.

2. Serum pregnancy test should be done in each visit.

3. Patients should be on Sacubitril + Valsartan (as sodium salt complex) 100mg(49mg+51mg) tablet stable dosing more than 1 month in inclusion criteria.

4. Patients with clinically significant impaired hepatic function (SGOT and SGPT should be more than 1X the UNL and/or total bilirubin more than 1X the UNL) in Exclusion criteria.

Accordingly, the expert panel suggested that the revised Phase III clinical trial protocol should be submitted to CDSCO for review.

Furthermore, the expert panel stated that after approval from CDSCO, the firm should submit a Phase III clinical trial report and a BE report under Fed conditions for further review by the committee.

Also Read:Torsemide, Dapagliflozin FDC not rational: CDSCO Panel Rejects Syngene's Proposal for BA/BE study