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Glenmark gets nod to manufacture & market anti-diabetic FDC of remogliflozin etabonate & teneligliptin
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Laxmi Yadav, Mumbai
June 23 , 2021
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The Subject Expert Committee (SEC) at the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Glenmark Pharmaceuticals to manufacture and market the proposed fixed dose combination (FDC) of remogliflozin etabonate and teneligliptin.
The FDC is indicated in adults aged 18 years and above with type 2 diabetes mellitus (T2DM). T2DM is an emerging epidemic in India where 8.9 per cent of the total population, equivalent to 77 million people, has diabetes.
With the advent of the SGLT2 inhibitor class of drugs demonstrating benefits beyond glycemic control, viz. weight loss, blood pressure reduction, and cardiovascular and renal protection, the management of T2DM has taken a quantum leap. remogliflozin etabonate is the latest addition to the SGLT2 inhibitor class of drugs that have been recently approved in India for the management of T2DM.
Teneligliptin is a medicine given to control raised blood sugar levels in patients with T2DM. It belongs to a class of anti-diabetic medicines called 'DPP-4 inhibitors' or 'Gliptins.
The phase III study of the FDC – remogliflozin etabonate (100mg)+teneligliptin hydrobromide hydrate equivalent to teneligliptin (10mg) film coated tablets has shown to improve glycaemic control when metformin and one of the mono-components of the FDC do not provide adequate glycaemic control.
In light of the earlier recommendations of SEC dated October 15, 2020, Glenmark presented the phase III clinical trial report before the committee.
After detailed deliberation, the committee in its meeting on June 15-16, 2021 recommended grant of permission for manufacturing and marketing the proposed FDC.
On October 15 last year, the firm presented the pharmacokinetic (PK) study data before the committee and requested for amendment in the phase III trial protocol. The committee observed that the drugmaker initiated the phase III trial without submitting the bioavailability (BA) study report which was not in accordance with the conditions of the clinical trial permission issued by CDSCO for which CDSCO might take appropriate action.
After detailed deliberation, the committee refused to give permission for amendment in the phase III clinical trial protocol.
Later the firm presented their protocols for BA study and phase-III clinical trial at SEC meeting on January 23, 2021.
After detailed deliberation, the committee recommended grant of permission to conduct the proposed BA study with the condition that one physician with postgraduate qualification shall be included in the study.
As regard to phase-III clinical trial protocol, the committee recommended grant of permission to conduct the proposed clinical trial study with the following condition: the rescue criteria should be revised to include fasting blood glucose (FBG) at 6 weeks should be 240 instead of 270 and there should be appropriate withdrawal criteria.
The trial should be initiated only after completion of BA study and results should be presented before the committee.
Accordingly, the firm presented phase III data of the FDC at the SEC meeting last week. After the deliberation, the panel gave green signal to the drug firm to manufacture and market the drug.
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