Nexium is approved for use in the EU
In 2000, the company AstraZeneca got a permission for use in all countries of the European Union (EU) of a new drug Nexium (esomeprazole), which belongs to a class of proton pump inhibitors.
The first time permission for the use of Nexium was received in March 2000 in Sweden, where the start of the drug’s promotion was scheduled for August 2000. This authorization also permits the use of Nexium in Norway and Iceland.
According to AstraZeneca, it will soon start promoting the drug in other EU countries. At present, the company negotiates with the competent authorities on the price of the drug and the reimbursement of its costs through the insurance system. Promotion of the drug in the UK is scheduled for the autumn. Nexium is expected to be approved in the U.S. (the registration documents were applied to FDA in December 1999), Canada, Australia, New Zealand and Switzerland.
From sales of Nexium that replaces Losec / Prilosec (omeprazole), AstraZeneca’s bestseller, depend the future growth of the company.
The share Losec / Prilosec in 1999 accounted for 40% of all AstraZeneca sales. The market immediately reacted to the announcement of the approval of the drug Nexium in the EU: the same day the company’s stock price rose by 25 pence, reaching a record of 31.80 pounds sterling.
The company AstraZeneca intends to make Nexium a drug number 1 in the class of proton pump inhibitors. In order to convince doctors in the benefits of Nexium compared with omeprazole, the company will have to work hard. Clinical practice data show that Nexium in a dose of 40mg is more effective than omeprazole prescribed in a standard dose of 20mg and lansoprazole in a standard dose of 30mg. Even if the evidence is sufficient to convince the doctors, generic omeprazole drugs still can compete with the brand one.
Nexium is approved as a drug for the treatment of gastro-esophageal reflux disease, including treatment of erosive esophagitis. In addition, the drug is intended to prevent the development of relapse in patients who have been cured for oesophagitis, eradication of H. pylori infection in combination with antibacterial drugs, treatment of associated with H. pylori duodenal ulcers, and prevention of recurrence of peptic ulcer in patients with H. pylori infection. Nexium has a similar safety profile with omeprazole (the most common adverse effects are headache, abdominal pain and diarrhea).