Akum Pharmaceutical gets CDSCO nod for BE study of FDC Bempedoic acid,Rosuvastatin

Published On 2022-07-08 13:00 GMT | Update On 2023-10-16 10:10 GMT

New Delhi: Pharmaceutical major, Akum Pharmaceutical has got go ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence study of Bempedoic acid 180mg/180mg/180mg /180mg plus Rosuvastatin calcium eq. to Rosuvastatin 5mg/10mg/20mg/40m g tablets for the treatment of high LDL-cholesterol conditions.

This nod is subjected to the condition that the firm should include Glomerular Filtration Rate (GFR) in the study.

This came in line with the bioequivalance (BE) study protocol in higher strength presented by the drug-maker Akum Pharmaceutical along with the request for a Phase III Clinical Trial study waiver for all proposed strengths before the committee.

On the basis of the presentation made, the committee did not recommend the proposed lower strengths i.e. Bempedoic acid 180mg/180mg/180mg +Rosuvastatin calcium eq. to

Rosuvastatin 5mg/10mg/20mg tablets.

Bempedoic acid is a drug used in conjunction with lifestyle modification and/or other agents for the treatment of refractory hypercholesterolemia.

Bempedoic acid is a prodrug that requires activation in the liver. The very long-chain acyl-CoA synthetase-1 (ACSVL1) enzyme is responsible for its activation to ETC-1002-CoA, the pharmacologically active metabolite. ATP lyase (also known as ATP synthase) plays an important part in cholesterol synthesis. BETC-1002-CoA directly inhibits this enzyme after the parent drug is activated in the liver by coenzyme A (CoA).

This inhibition leads to upregulation of the LDL cholesterol receptor, reducing serum LDL-C via increased uptake and LDL clearance in the liver. By the above mechanisms, bempedoic acid causes a total decrease of circulating LDL-C that normally damages blood vessels and leads to atherosclerosis. Lastly, ETC-1002 activates AMP-activated protein kinase (AMPK) in rodents, which inhibits the synthesis of cholesterol via the inhibition of HMG-CoA reductase. The relevance of this to humans is unknown.

Rosuvastatin is a statin medication and a competitive inhibitor of the enzyme HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, which catalyzes the conversion of HMG-CoA to mevalonate, an early rate-limiting step in cholesterol biosynthesis. Rosuvastatin acts primarily in the liver, where decreased hepatic cholesterol concentrations stimulate the upregulation of hepatic low density lipoprotein (LDL) receptors which increases hepatic uptake of LDL. Rosuvastatin also inhibits hepatic synthesis of very low density lipoprotein (VLDL). The overall effect is a decrease in plasma LDL and VLDL.

At the recent SEC meeting for Cardiovascular and Renal held on 22.06.2022, the expert panel reviewed the proposal and BE study protocol for Bempedoic acid 180mg/180mg/180mg /180mg+Rosuvastatin calcium eq. to Rosuvastatin 5mg/10mg/20mg/40m g tablets.

After detailed deliberation, the committee recommended for grant of permission to conduct the proposed BE study with the condition to include GFR in the study.

In addition, with regard to the clinical trial study waiver, the committee recommended that the firm should initially present the BE study results before the committee for further consideration of the Phase III CT waiver at that point in time

Also Read:CDSCO panel recommends emergency use nod for Gennova Biopharma mRNA COVID vaccine

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Akum Pharmaceutical gets CDSCO nod for BE study of FDC Bempedoic acid,Rosuvastatin

Similar News

Ravenbhel's Bilastine, Montelukast FDC Under Review, CDSCO Panel Seeks Pediatric Expert Opinion

From Breakthrough to Backlash: Novo Nordisk's Ozempic Faces USD 2 Billion Lawsuit

Aurobindo Pharma Clarifies Zentiva Acquisition Reports 'Premature', No Binding Pact Finalised

CDSCO Digitisation Cuts Post-Approval Change Timelines in CGTs from 218 to 98 Days: DCGI

PLI scheme brings down cost of rare disease treatment from crores to lakhs

Aurobindo Pharma in lead to acquire Zentiva for US 5.5 billion: ET Report

Parexel appoints Jim Anthony to expanded role as CCO, President, Parexel Biotech

Gas leak at Maha Pharma co kills 4, injures 2