CDSCO Panel Tells Akums to submit rationale for FDC Bempedoic acid, Atorvastatin, Ezetimibe film-coated tablet
New Delhi: Responding to the proposal presented by the drug major Akum Pharmaceuticals regarding the fixed-dose combination drug containing Bempedoic acid, Atorvastatin, and Ezetimibe, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation(CDSCO) has opined the firm to present adequate justification/rationale for the proposed triple drug combination.
This came after the expert panel noted a lack of adequate justification or rationale for the proposed three-drug combination and the absence of global data related to the proposed fixed-dose combination (FDC).
Bempedoic acid is in a class of medications called adenosine triphosphate-citrate lyase (ACL) inhibitors. It works by blocking the production of cholesterol in the liver.
Bempedoic acid is used together with diet and other cholesterol-lowering medicines (e.g., statins) to treat patients with heterozygous familial hypercholesterolemia (HeFH) and patients with heart disease who need additional lowering of their bad cholesterol (LDL) levels.
Atorvastatin is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, and triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver.
Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.
Ezetimibe is a medication used in the management and treatment of hypercholesterolemia. It is among a novel class of selective cholesterol-absorption inhibitors.
Ezetimibe is used to treat high blood cholesterol. You may also be prescribed ezetimibe if you cannot take cholesterol-lowering medicines called statins, or if a statin medicine does not work for you. Ezetimibe is available on prescription only. It comes as a tablet.
Research findings demonstrated that in individuals with high cholesterol levels, the concurrent use of bempedoic acid, ezetimibe, and atorvastatin resulted in a noteworthy reduction in LDL-C levels.
At the recent SEC meeting for Cardiovascular and Renal held on 06th September 2023, the expert panel reviewed the proposal presented by the drug major Akum Pharmaceuticals regarding the proposed triple drug combination Bempedoic acid plus Atorvastatin Calcium IP eq. to Atorvastatin plus Ezetimibe IP(180mg+20mg+10 mg)/ (180mg+40mg+10mg ) film-coated tablet.
Following a thorough discussion, the committee expressed the following opinions:
1. The lower dose of statins along with Bempedoic acid is not approved in the country.
2. The firm has not presented adequate justification/rationale for the proposed triple drug combination.
3. More published scientific literature in peer-reviewed journals in support of triple-drug combinations is to be presented.
4. No global data was presented with respect to the proposed fixed-dose combination (FDC).
In view of the above, the committee recommended that the firm should present the documents/justification on aforesaid points before the SEC for further review.
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