Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan
New Delhi: In response to the justification presented by the drug major Lupin on the rationality of the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus Valsartan tablet 25 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to submit more justification on the proposed dose and its rationality for further evaluation.
This came after the drug maker Lupin presented justification for the proposed dose and its rationality, along with the Phase III clinical trial protocol, before the committee.
Sacubitril is a neprilysin inhibitor used in combination with valsartan as an adjunct to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
Sacubitril is a prodrug that is activated to sacubitrilat 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. A lower blood pressure will increase the supply of blood and oxygen to the heart.
The FDC of Sacubitril and valsartan 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).
Earlier, the Medical Dialogue Team had reported that Lupin had presented its proposal along with justification for bioequivalence (BE) waiver and Phase-III clinical trials (CT) waiver before the committee at the SEC meeting for cardiovascular held on January 9, 2024, where the expert panel suggested the firm submit more justification on the proposed dose and rationality of the fixed-dose combination (FDC) cardiovascular drug Sacubitril plus Valsartan tablet 25 mg.
In continuation, at the recent SEC meeting for cardiovascular held on July 18, 2024, the expert panel reviewed the justification of the proposed dose and its rationality along with the Phase III clinical trial protocol presented by drug maker Lupin.
After detailed deliberation, the committee reiterated its earlier recommendations to submit more justification on the proposed dose and its rationality to CDSCO for further review by the committee.
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