SEC recommends approval for Dr Reddy’s gastrointestinal drug Tegoprazan

The Subject Expert Committee (SEC) of the central drug regulatory authority has recommended grant of approval to Dr Reddy’s Laboratory for import and market new drug Tegoprazan in the country for use in various gastrointestinal diseases.
The proposal was for approval of Tegoprazan tablets 25mg and 50 mg. Dr Reddy’s Laboratories has in 2022 announced an exclusive partnership with South Korea-based HK inn.N Corporation for the supply and commercialisation of the latter’s patented novel molecule for gastrointestinal diseases in India and six key emerging markets.
The company presented the proposal of grant of permission to import and market of new drug Tegoprazan tablet 50 and 25 mg along with pharmacokinetics study report and phase III global clinical trial study report before the SEC for gastroenterology and hepatology.
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 study.
Accordingly, the committee recommended for the grant of permission to import and market of Tegoprazan tablet 50 mg for the indications of erosive gastroesophageal reflux disease (GERD), non-erosive gastroesophageal reflux disease (NERD), and gastric ulcer.
It has also recommended permission to import and market of new drug Tegoprazan tablet 25 mg for maintenance of healed erosive gastroesophageal reflux disease.
Further, the committee also recommended that for the indication with regard to adjuvant to Heliobacter pylori bacterial infection, a common cause of stomach ulcers, in combination with antibiotics, the firm is required to conduct phase III clinical trial in Indian population as the global data on H. pylori treatment with Tigrayan is limited and resistance pattern are different across the countries.
The company earlier claimed that Tegoprazan, a molecule containing novel potassium-competitive acid blockers (P-CABs), is an innovative potent and highly selective inhibitor of gastric H+/K+-ATPase that will provide a new option for the treatment of gastric acid-related and motility-impaired diseases such as GERD, NERD, gastric and duodenal ulcers, nonsteroidal anti-inflammatory drug-mediated ulcers, and H.pylori eradication. The drug induces fast onset of action and can control gastric pH for a prolonged period, potentially offering significant clinical benefit in acid-related disorders, it added.
The company, while announcing the exclusive partnership in 2022, said that the South Korean partner will be responsible for the manufacture and supply of Tegoprazan, while Dr. Reddy’s will be responsible for local clinical development, registration, marketing and sales in the licensed territories.
The agreement also granted Dr. Reddy’s the exclusive rights to develop and commercialise Tegoprazan under its own trademark in these markets for 10 years from the first commercial launch. HK inno.N Corporation will receive an upfront licensing fee, and will be eligible for potential regulatory milestone payments and royalties on net product sales, it added during the time.
Source: Pharmabiz