AstraZeneca gets first approval for omeprazole follow-up Nexium

AstraZeneca has gained its first regulatory approval for Nexium(esomeprazole), the eagerly-anticipated follow-up drug to its bestselling antiulcerant Losec/Prilosec (omeprazole). The Swedish Medical Products Agency approved the drug for a broad range of indications on March 13, setting Nexium up for approval throughout the European Union under the mutual recognition procedure.

The company said that it now plans to launch the product in Sweden in the second half of the year, with several other European introductions expected before the year-end. The approval has come earlier than expected, within just five months of the filing for the drug in Sweden, and reflects the quality of the firm's dossier, which included data on 15,000 patients. AstraZeneca will now undertake pricing negotiations with the Swedish authorities, followed by mutual recognition, pricing and labeling procedures in other EU member states. Analysts at Goldman Sachs are predicting a Swedish launch in August, six months earlier than expected, followed by a September/ October introduction in the UK and Germany.

Nexium has received approval for each of its requested indications, including the healing and management of gastro-esophageal reflux disease, healing of Helicobacter pylori-associated duodenal ulcers and, crucially, the on-demand treatment of heartburn and GERD. This latter indication is the first for any proton pump inhibitor and will allow AstraZeneca to immediately differentiate Nexium from both Losec and its competitors with a superiority claim. On-demand treatment allows doctors to prescribe Nexium to patients, who then take the medication once-daily, when needed, to control their recurrent symptoms. Clinical studies have shown that after six months' treatment, 90% of patients using Nexium on-demand had controlled symptoms.