Dr Reddys Laboratories gets CDSCO Panel Nod to import, market Tegoprazan for gastrointestinal diseases
New Delhi: In a significant development, the pharmaceutical major Dr Reddys Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market potassium-competitive acid blocker (P-CAB), a new type of gastric acid secretion inhibitor, Tegoprazan tablets 50 and 25 mg.
The committee has permitted the importation and marketing of Tegoprazan tablets: 25 mg for the maintenance of healed erosive gastro-oesophageal reflux disease, 50 mg for erosive gastro-oesophageal reflux disease, non-erosive gastro-oesophageal reflux disease, and gastric ulcer.
However, in addition to the above, the committee also recommended that for the indication with respect to adjuvant to H. pylori in combination with antibiotics, the firm is required to conduct a phase III clinical trial in the Indian population as the global data on H. pylori treatment with Tegoprazan is limited and resistance patterns are different across the countries.
This came after the drug major, Dr. Reddys Laboratories, presented the proposal of grant of permission to import and market the new drug Tegoprazan tablet 50 and 25 mg along with a pharmacokinetic (PK) study report and a Phase III global clinical trial study report before the committee.
Tegoprazan is a novel therapeutic indicated for treating acid-related gastrointestinal diseases. This drug is a potent and highly selective potassium-competitive acid blocker (P-CAB) with a fast onset of action and the ability to control gastric pH for a prolonged period of time.
Tegoprazan works as a potassium-competitive acid blocker that is potent and highly selective. Its mechanism of action is different from that of the proton-pump inhibitors, as this drug does not require conversion into an active form and can directly inhibit H+/K+ ATPase in a reversible and K+‐competitive way. This is because it is an acid-resistant weak base with the ability to remain in the highly acidic canaliculi of gastric parietal cells.
At the recent SEC meeting for gastroenterology and hepatology, the expert panel reviewed the proposal of grant of permission to import and market the new drug Tegoprazan tablet 50 and 25 mg along with a pharmacokinetic (PK) study report and a Phase III global clinical trial study report.
After detailed deliberation, the committee noted that the firm has completed Phase III Global clinical trial study, and India is one of the participating countries in the said Phase III Global CT study.
Accordingly, the committee recommended the grant of permission to import and market the new drug Tegoprazan Tablet 50 mg for the following indication:
1. Erosive Gastroesophageal Reflux Disease
2. Non-erosive Gastroesophageal Reflux Disease
3. Gastric ulcer
In addition, the expert panel granted approval to import and market the new drug Tegoprazan Tablet 25 mg for the following indication:
1. Maintenance of healed Erosive Gastroesophageal Reflux Disease
Furthermore, the committee also recommended that for the indication with respect to adjuvant to H. pylori in combination with antibiotics, the firm is required to conduct a phase III clinical trial in the Indian population as the global data on H. pylori treatment with Tegoprazan is limited and resistance patterns are different across the countries.
