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December 2, 2013

Eisai seeks indication expansion for Pariet in Japan

Japanese pharmaceutical firm Eisai has filed an application for the proton pump inhibitor (PPI) Pariet (rabeprazole sodium, rabeprazole) in Japan for a further indication expansion for use in the prevention of recurrent gastric or duodenal ulcer caused by low-dose aspirin therapy as well as the approval for a new 5mg tablet formulation.

By admin-demo

Japanese pharmaceutical firm Eisai has filed an application for the proton pump inhibitor (PPI) Pariet (rabeprazole sodium, rabeprazole) in Japan for a further indication expansion for use in the prevention of recurrent gastric or duodenal ulcer caused by low-dose aspirin therapy as well as the approval for a new 5mg tablet formulation.

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The application is based on data secured from a double-blind comparative Phase II/III trial carried out in 472 patients who required long-term administration of low-dose aspirin and who were confirmed to also have a history of gastric or duodenal ulcer.

Results of the trial showed a reduction in the cumulative incidence of recurrent gastric or duodenal ulcer among the patient groups administered 5mg and 10mg of rabeprazole respectively, when compared with a comparator, showing the superiority of rabeprazole in preventing ulcer recurrence.

"Adverse events (AEs) in the trial were consistent with the known safety profile of rabeprazole and no new or unexpected AEs occurred."

In addition, adverse events (AEs) in the trial were consistent with the known safety profile of rabeprazole and no new or unexpected AEs occurred.

Pariet was first launched in Japan in 1997 and is currently approved in more than 100 countries worldwide.

The drug is indicated for multiple uses, including the treatment of gastric ulcer, duodenal ulcer, reflux esophagitis, non-erosive gastroesophageal reflux disease, and as an adjunct therapy in several types of Helicobacter pylori (H pylori) eradication, including in patients with gastric ulcer, duodenal ulcer, or H pylori gastritis.

The company said that by expanding the existing indications for Pariet and receiving approval for the new 5mg tablet formulation, it aims to increase the clinical value of the drug to further contribute to the range of treatment options available to patients with acid-related diseases.

In August, Eisai received marketing authorisation in Japan for two types of triple formulation packs (combination packs) for H pylori eradication, which both contain Pariet.

The drug firm is also conducting a Phase III study in Japan on Pariet as a maintenance therapy for patients with reflux esophagitis resistant to once-daily PPI treatment.

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Given the background of high inflation, re-emerging supply chain issues, and the widespread macro-economic implications of the Ukraine conflict, the global pharmaceutical industry is facing an entirely new set of challenges following the turbulence of the COVID-19 pandemic. GlobalData’s World Markets Healthcare (WMH) service has released its latest Q2 forecast. This report incorporates the latest thinking on the opportunities and risks this new environment presents for pharma companies. However, the pharma sector is proving resilient, and we are projecting 4.4% global growth for the year ahead. Yet it remains that the current economic picture is inverting some baseline assumptions from previous quarterly forecasts and altering which markets we expect the key growth levers to derive from. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies.
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