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news.Japan-based pharmaceutical business Takeda Pharmaceutical Company and its wholly-owned subsidiary, Takeda Pharmaceuticals North America have announced that the FDA has approved Kapidex delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease, the healing of erosive esophagitis and the maintenance of healed erosive esophagitis.
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Kapidex (30mg and 60mg) is the first proton pump inhibitor (PPI) with a dual delayed release formulation designed to provide two separate releases of medication.
The approval was based on global studies conducted in 20 countries evaluating approximately 6,000 patients with erosive and non-erosive gastroesophageal reflux disease.
Alan MacKenzie, president and CEO of Takeda Pharmaceuticals North America, said: “Through the discovery, development and commercialization of new medicines, Takeda has been a leader in acid-related therapy for more than 15 years and is committed to bringing new therapies to market. Kapidex is a new, innovative treatment option in the well-established PPI market.”