Japan cleared Ozempic for type 2 diabetes in March 2018, with Rybelsus tablets following in 2020

Japan's drug regulator cleared Ozempic Subcutaneous Injection 2 mg for type 2 diabetes in March 2018, giving the country an injectable form of semaglutide ^[1]. The oral version, Rybelsus 3 mg tablets, was approved for the same indication in June 2020 ^[1]. Both products contain semaglutide, the same active ingredient that Novo Nordisk later sells as Wegovy for weight management ^[1].

Semaglutide is a glucagon-like peptide-1 (GLP-1) analog ^[1]. Wegovy, the higher-dose injectable form, is expected to produce weight loss by activating areas of the brain involved in appetite regulation through the GLP-1 receptor ^[1]. Novo Nordisk Pharma filed its Japanese application for Wegovy on August 25, 2021 ^[1].

The Japanese review of Wegovy ran alongside the earlier diabetes approvals. A review report dated December 27, 2022 concluded the product has efficacy in the treatment of obesity disease and acceptable safety in view of its benefits ^[1]. At a meeting on January 27, 2023, the First Committee on New Drugs concluded the product may be approved ^[1]. The approval carried a four-year re-examination period, a requirement that the company develop and carry out a risk management plan, and a classification as a powerful drug ^[1].

Label criteria differ by country. Japan's approved Wegovy indication limits use to patients with hypertension, dyslipidemia, or type 2 diabetes who have not responded adequately to diet and exercise and who have either a BMI of at least 27 kg/m2 with at least two obesity-related health disorders, or a BMI of at least 35 kg/m2 ^[1]. In the United States, Wegovy was approved in June 2021 for a BMI of 27 kg/m2 or greater in the presence of at least one weight-related condition, such as hypertension, type 2 diabetes, or dyslipidemia ^[1]. The European Union approved it in January 2022 for a BMI of at least 30 kg/m2, or 27 to under 30 kg/m2 with at least one weight-related comorbidity ^[1]. As of June 2022, Wegovy had been approved in six countries or regions ^[1].

Details such as the price of Ozempic in Japan, how quickly it was prescribed there after March 2018, and whether the 2018 review weighed cardiovascular outcomes have not been reported ^[1].

Why it matters for patients

The Japanese approvals show that a single molecule can reach the market under different names, doses, and rules. Ozempic and Rybelsus are semaglutide approved for type 2 diabetes; Wegovy is semaglutide approved for obesity ^[1]. A diabetes approval in one country does not automatically mean the same drug is cleared for weight management there, and the eligibility thresholds are not identical across borders. Japan's obesity label is narrower than the US label in one respect, requiring either two obesity-related disorders at a BMI of at least 27 or a BMI of at least 35, and restricting use to patients who also have hypertension, dyslipidemia, or type 2 diabetes ^[1].

For US patients, the March 2018 decision in Japan does not change what is available, covered, or prescribed in the United States. It is a record of when regulators in another major market first cleared this molecule, and of how the same active ingredient was later reviewed for a different purpose.

What happens next

In Japan, the Wegovy approval requires Novo Nordisk to develop and carry out a risk management plan, and the product stays under a four-year re-examination period ^[1]. That means Japanese regulators continue collecting safety data on the drug after approval rather than closing the file.