Novartis Announces NMPA Approval of New Indication for Eltrombopag Olamine Tablets in China

On February 24, the official website of the National Medical Products Administration (NMPA) announced that Novartis' eltrombopag ethanolamine tablets (brand name: Revolade) had received approval for a new indication.

Eltrombopag Olamine Tablets, a non-peptide thrombopoietin receptor (TPO-R) agonist developed by Novartis, were approved by the FDA in November 2008 for the treatment of chronic immune (idiopathic) thrombocytopenia (ITP) in patients who had previously shown inadequate response to treatments such as corticosteroids and immunoglobulins. This made it the world's first oral medication for this indication. In addition to ITP, Eltrombopag Olamine Tablets have also been approved in the United States for the treatment of thrombocytopenia associated with chronic liver disease and aplastic anemia.

In December 2017, the product entered the Chinese market. With the expansion of the applicable population, eltrombopag olamine tablets can now be used in China to treat chronic immune (idiopathic) thrombocytopenia in patients aged 6-11 years and over 18 years who have had an inadequate response to previous treatments such as corticosteroids and immunoglobulins.

Since its launch, the sales of Eltrombopag Ethanolamine Tablets have continued to grow, with a global revenue of $2.088 billion in 2022.

Currently, five drugs targeting the TPO receptor have been launched in China, including Eltrombopag Olamine Tablets (Novartis), Hetrombopag Olamine (Hengrui), Romiplostim (Kyowa Kirin), Avatrombopag Maleate Tablets (Fosun Pharma), and Recombinant Human Thrombopoietin (Shenyang Sunshine Pharmaceutical).

Notably, several Chinese pharmaceutical companies have also submitted applications for the market approval of their generic versions of Eltrombopag Ethanolamine Tablets, including Aosaikang Pharmaceutical, Zhengdatianqing, Qilu Pharmaceutical, Kelun Pharmaceutical, Changzhou Pharmaceutical Factory, and Grand Pharmaceutical.

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