Nexium for aspirin-induced ulcers among new indications approved in Japan
This article was originally published in Scrip
Japan's ministry of health, labour and welfare has approved a number of products for additional indications, including AstraZeneca's Nexium (esomeprazole) for the prevention of recurrence of gastric and duodenal ulcers in patients being treated with low doses of acetylsalicylic acid.
The proton pump inhibitor is already marketed in Japan for the treatment of gastric, duodenal and anastomic ulcers, reflux oesophagitis (as both primary and maintenance therapy), non-erosive reflux disease, Zollinger-Ellison syndrome and the prevention of recurrence of gastric and duodenal ulcers in patients treated with NSAIDs. It is also used as an adjunct for the eradication of the gut bacterium Helicobacter pylori in various disease settings, including ulcers and idiopathic thrombocytopenic purpura.
Acetylsalicylic acid (aspirin) is used widely as a blood-thinning agent in patients at risk of myocardial infarction and ischaemic stroke, but long-term use is associated with an increased risk of peptic ulcers. Nexium's approval in the new indication in Japan, where it is partnered with Daiichi Sankyo, was supported by an Asian Phase III trial programme that included sites in Japan, South Korea and Taiwan.
AstraZeneca also received regulatory clearance for two other products in new uses, including Symbicort Turbuhaler (budesonide plus formoterol fumarate hydrate) for the on-demand relief of adult bronchial asthma. One inhalation, which delivers 160mcg of budesonide, a corticosteroid, and 4.5mcg of formoterol fumarate hydrate, a rapid- and long-acting beta2 agonist, can now be taken at the onset of an attack, plus a further single inhalation after a few minutes if necessary, up to a maximum of six doses per attack.
The dry powder product was launched for regular use as a maintenance therapy for bronchial asthma (a single inhalation twice-daily, up to four inhalations twice daily) in early 2011 in Japan, where it is sold through Astellas.
The UK group's ACE inhibitor Zestril (lisinopril) was also approved for the additional indication of hypertension in paediatric patients (aged six years or older), following a request from a special committee of the ministry that is working to identify unapproved products for outstanding medical needs.
Standard and oral-dissolving tablet formulations of Dainippon Sumitomo Pharma's Amlodin (amlodipine; licensed from Pfizer) were also granted regulatory clearance for the same use, also based on an official request and using data already in the public domain. The calcium antagonist is currently marketed for adult hypertension and angina pectoris, and the firm notes that high blood pressure has been reported to affect around 3% of high school students in Japan.
Pfizer's anticonvulsant Lyrica (pregabalin) became the first drug treatment to be approved in the country for pain associated with fibromyalgia, adding to its present uses of post-herpetic neuralgia and peripheral neuropathic pain (including post-herpetic neuralgia), both of which were approved in 2010.
The product, co-promoted locally with partner Eisai, was approved for the new indication based on comparative and long-term Phase III studies conducted in Japan.