Novartis' Imported Drug Revolade (Eltrombopag) for Severe Aplastic Anemia Included in China's National Reimbursement Drug List

　　【Pharmaceutical Network Product InformationAplastic Anemia (AA) is a type of bone marrow failure hematological disease caused by a reduction in the number of hematopoietic stem cells and dysfunction due to various reasons. Its symptoms are not obvious in the early stages, making it difficult to detect. Data shows that the annual incidence rate of AA in China is approximately 0.74 per 100,000. The peak age groups for incidence are 15-25 years and 65-69 years. Based on the severity of bone marrow failure, AA is generally divided into non-severe and severe types. Among them, the annual incidence rate of Severe Aplastic Anemia (SAA) in China is roughly 1.4-1.7 per million, characterized by acute onset, severe condition, and posing a serious threat to life and health.
 

On February 21, 2023, Novartis' eltrombopag (Revolade) received approval for a new indication to treat patients with severe aplastic anemia (SAA) who have had an insufficient response to prior immunosuppressive therapy, offering a new treatment option for relevant patients.
 

Studies show that for East Asian patients over 60 years old with severe aplastic anemia, after receiving no less than 6 months of eltrombopag (75mg qd) treatment, the overall response rate can exceed 70%. Moreover, in the population aged between 60 to 70 years, the overall efficacy and remission rate of using this combined regimen are similar to the results observed in the overall adult population.
 

Reportedly, Novartis' eltrombopag olamine tablets were approved for marketing by the FDA in November 2008. On July 21, 2018, Novartis announced that the drug was officially approved for marketing in China to treat thrombocytopenia in patients with chronic primary immune thrombocytopenia (ITP) who are unresponsive to treatment with glucocorticoids or immunoglobulins, or who have undergone splenectomy. On May 20, 2022, Novartis announced that a new indication for eltrombopag olamine tablets was approved in China for the treatment of chronic immune (idiopathic) thrombocytopenia in children aged 6-11 years who have had an inadequate response to previous treatments such as glucocorticoids and immunoglobulins.
 

This medication has been recommended for use in the "Chinese Guidelines for the Diagnosis and Treatment of Aplastic Anemia (2022 Edition)," "Chinese Guidelines for the Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia (2020 Edition)," and "Standards for Diagnosis and Treatment of Childhood Primary Immune Thrombocytopenia (2019 Edition)."
 

Data shows that Novartis' Eltrombopag Ethanolamine Tablets have achieved considerable sales in the U.S. market, with global sales reaching $2.016 billion in 2021.
 

However, apart from Novartis, domestic pharmaceutical companies in China are also actively positioning themselves in the field, which will bring more medication options to patients in China in the future. For instance, on December 19, Shenyang Sunshine Pharmaceutical, a subsidiary of 3SBio, reached a project cooperation agreement with a company under Zhezheng Medicine. The two parties have agreed on a series of collaborations including technical development and commercialization of Zhezheng Medicine's self-developed Eltrombopag Olamine for Oral Suspension. It is reported that this product is the first dry suspension drug in the TPO-RA category to be submitted for marketing authorization in China. It has completed formulation process development, process and analytical method transfer, process validation, as well as bioequivalence (BE) studies, and the registration documents for this product were submitted in October 2023. Indications include Primary Immune Thrombocytopenia (“ITP”) and Severe Aplastic Anemia (“SAA”).
 

In addition to making drugs available to patients, relevant departments in China are also actively promoting the inclusion of new drugs in the medical insurance program. Recently, the highly anticipated 2023 updated version of the National Reimbursement Drug List (NRDL) has been released. Novartis successfully included two new products and two new indications in the 2023 NRDL. Among them is Promacta® (Eltrombopag Olamine Tablets), which has a newly added indication for "treating severe aplastic anemia (SAA) patients who have had an insufficient response to prior immunosuppressive therapy." This means that it will help reduce the medication costs for SAA patients in China.
 

On August 22, 2019, Eltrombopag was included in the Class B range of anti-hemorrhagic drugs covered by medical insurance, offering ITP patients a new treatment option while effectively reducing their medical burden.
 

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