Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan
New Delhi: In response to the proposal presented by the drug major Lupin for the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus Valsartan, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the more justification on the proposed dose and rationality of the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus Valsartan tablet 25mg.
This came after the drug major Lupin presented its proposal along with justification for bioequivalence (BE) waiver and Phase-III clinical trials (CT) waiver before the committee.
Sacubitril is a prodrug that is activated to sacubitrilat (LBQ657) by de-ethylation via esterases. Sacubitrilat inhibits the enzyme neprilysin, which is responsible for the degradation of atrial and brain natriuretic peptides, two blood pressure–lowering peptides that work mainly by reducing blood volume.
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.
Sacubitril and Valsartan combination treats heart failure by relaxing the blood vessels and making it easier for the heart to pump blood throughout the body. In addition, it also helps the body retain less water.
At the recent SEC meeting for cardiovascular held on 9th January 2024, the expert panel reviewed the proposal along with justification for BE waiver and Phase III CT waiver for the cardiovascular drug Sacubitril and Valsartan Tablets.
After detailed deliberation, the committee opined that more justification on the proposed dose and its rationality should be submitted for further review by the committee.
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