AstraZeneca's Ticagrelor Orodispersible Tablets Nearing Approval in China

On August 28, AstraZeneca’s marketing application for ticagrelor dispersible tablets in China entered the “under review” stage, with approval expected in the near future.

Ticagrelor is a novel antithrombotic agent. AstraZeneca has developed three formulations: tablets, orally disintegrating tablets, and dispersible tablets. All three formulations have been approved for marketing in the European Union; however, only the tablet formulation has been approved for import in China. The dispersible tablet is designed to provide a new option for patients with dysphagia or those who can only be treated via tube administration. In acute settings, the dispersible tablet eliminates the need to crush tablets or seek drinking water.

Ticagrelor is one of AstraZeneca’s blockbuster drugs, with global sales reaching USD 1.581 billion in 2019. In China, generic ticagrelor tablets from seven manufacturers have already been approved for marketing and have passed the consistency evaluation, and this dosage form has been included in the volume-based procurement program. Regarding other dosage forms, the ticagrelor sustained-release capsules developed by Jiangsu Hengrui Medicine have been approved to commence clinical trials.