When was avatrombopag officially launched?

Avatrombopag (trade name: Doptelet) is an oral thrombopoietin receptor agonist mainly used to treat thrombocytopenia. The drug’s marketing history is as follows:

1. First approval for marketing in the United States

Avatrombopag was approved by the U.S. Food and Drug Administration (FDA), becoming the first oral TPO receptor agonist to treat thrombocytopenia in patients with chronic liver disease (CLD) before undergoing medical or dental procedures. The approval is based on the results of two international multi-center, randomized, double-blind, placebo-controlled Phase III clinical trials of ADAPT-1 and ADAPT-2, which showed that the drug can significantly reduce the proportion of patients who require platelet transfusions before surgery.

2. Expand indications to chronic immune thrombocytopenia (ITP)

Following the initial approval, avatrombopag was approved on20196month27 was once again approved by the FDA for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to prior treatment. This makes avatrombopag the first oral TPO receptor agonist approved for both CLD-related thrombocytopenia and chronic ITP, providing patients with more treatment options.

3. Listing status in China

Avatrombopag was approved by the China National Medical Products Administration (NMPA) in July 2020 and was officially launched in China. The introduction of this drug provides a new treatment option for Chinese patients with chronic liver disease and immune thrombocytopenia.

4. Approvals in other regions around the world

In addition to the United States and China, avatrombopag has also been approved in other countries and regions. For example, on 2019 on 6month20, the EU approved The drug is approved for the treatment of chronic immune thrombocytopenia; in January 2023, Australia also approved the use of the drug. These approvals further expand avatrombopag’s global accessibility.

In general, since avatrombopag was first launched in the United States in 2018, it has been gradually approved in many countries and regions around the world and has become one of the important drugs for the treatment of thrombocytopenia.

Reference materials:https://go.drugbank.com/drugs/DB11995