Japanese approval for AstraZeneca's Nexium and added indications for Chugai drugs

AstraZeneca this morning revealed that its blockbuster gastrointestinal drug Nexium (esomeprazole magnesium) 10mg and 20mg capsules has received regulatory approval in Japan for the treatment of acid-related  conditions including non-erosive reflux disease (NERD), reflux esophagitis and peptic ulcer disease (PUD). Nexium also received regulatory approval for prevention of recurrence of gastric ulcer and duodenal ulcer in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs).

Nexium is currently available in more than 120 countries and is the world’s leading proton pump inhibitor (PPI) with annual sales of almost $5 billion in 2010. AstraZeneca plans to launch the drug in Japan, where the PPI market is valued at $2 billion, in the second half of 2011. In a previously-announced co-promotion agreement, AstraZeneca will manufacture and develop Nexium and Daiichi Sankyo will be responsible for its distribution in Japan.

The regulatory approval of Nexium was based on eight clinical studies conducted in Japan, including two large comparative efficacy and safety studies of patients with reflux esophagitis and two comparative efficacy and safety studies in patients taking non-steroidal anti-inflammatory drugs (NSAIDs).