CDSCO panel Rejects Akum Pharma's FDC Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe
New Delhi: Reviewing the justification presented by the drug major Akum Pharmaceutical with respect to the triple-drug combination of Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected proposal the proposed fixed-dose combination (FDC).
This came after Akum Pharmaceutical presented its proposal for Bempedoic acid plus Atorvastatin Calcium IP eq. to Atorvastatin plus Ezetimibe IP (180mg+20mg+10mg)/ (180mg+ 40mg+10mg) film-coated tablet along with the justification.
Bempedoic acid is a drug used in conjunction with lifestyle modification and/or other agents for the treatment of refractory hypercholesterolemia.
Bempedoic acid is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease that warrants additional lowering of LDL-C. The combination of bempedoic and ezetimibe is also indicated with diet management and maximally tolerated statin therapy to treat elevated LDL-C levels in adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease who require further lowering of LDL-C.
Atorvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is needed by the body to make cholesterol, and this reduces the amount of cholesterol in the blood. This medicine is available only with your doctor's prescription.
Ezetimibe is used to treat high blood cholesterol. Ezetimibe is available on prescription only. It comes as a tablet.
Earlier, at the 133rd SEC meeting for cardiovascular and renal, regarding the proposed FDC Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe, the expert panel recommended that the firm should present the documents/justification on the following points:
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 combination is to be presented.
4. No global data was presented with respect to the proposed FDC.
In response to the above, at the recent SEC meeting for Cardiovascular on 20th February 2024, Akum Pharmaceutical presented their proposal along with the justification.
In continuation, the expert panel reviewed the proposal along with the justification for the FDC Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe presented by the drug major Akum Pharmaceutical.
After detailed deliberation, the committee opined that the firm could not present a detailed justification with respect to the following:
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. No global data was presented with respect to the proposed FDC.
After detailed deliberation, the committee did not recommend approval of the FDC.
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