UK-based pharmaceutical major AstraZeneca (NASDAQ: AZN) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Nexium (esomeprazole) to treat gastroesophageal reflux disease (GERD) in adolescents. This marks the proton pump inhibitor’s (PPI) first approval for a pediatric indication in China.
Incidence and Treatment of GERD in Children
The incidence of gastroesophageal reflux (GER) in children is as high as 75%. Drug therapy is the first choice for treatment, including acid inhibitors and antacids, mucosal protectants, motivators, and proton pump inhibitors. PPIs block the final step of gastric acid secretion by gastric parietal cells through irreversible combination with H+-K+-ATPase (commonly known as the proton pump) on gastric parietal cells, thereby playing an acid-inhibiting role and providing a good prognosis.
Nexium’s Clinical Evidence and Approval Basis
Nexium boasts more than 20 years of children’s clinical research evidence overseas and abundant pediatric post-marketing data. The approval by the NMPA is based on the combination of overseas data and data extrapolation. This approval highlights AstraZeneca’s commitment to addressing significant unmet medical needs in pediatric GERD treatment.-Fineline Info & Tech
