Is molotinib/mometinib on the market?

Momelotinib (Momelotinib) is an anti-cancer drug used to treat myelofibrosis. It was approved by the U.S. Food and Drug Administration (FDA) in September 2023 n> and were approved for medical use in the European Union by the European Medicines Agency (EMA) in January 2024, and are sold under Ojjaara and other brands. Molotinib is a Janus kinase inhibitor that is administered orally. Its main effect is to improve the symptoms of patients with myelofibrosis.

The benefits of molotinib outweigh its risks and it can be authorized for use. Molotinib has been shown to improve symptoms of myelofibrosis in patients with moderate to severe anemia who were not treated with a JAKi or who had been treated with the JAKi inhibitor ruxolitinib. These symptoms include an enlarged spleen (such as pain under the ribs on the left side of the body and premature satiety), anemia (including the need for a blood transfusion), and other symptoms of myelofibrosis (such as fatigue, itching, and bone pain). Therefore, molotinib is considered to meet a medical need in patients with myelofibrosis, particularly those with moderate to severe anemia who initially exhibit or continue to develop symptoms of myelofibrosis despite prior treatment with the JAKi inhibitor ruxolitinib.

Although molotinib has many potential benefits, there are also concerns about its adverse effects. The most common adverse reactions include dizziness, fatigue, bacterial infection, bleeding, thrombocytopenia, diarrhea and nausea. However, overall, the safety profile of molotinib is considered acceptable and its use may therefore be considered for authorization in specific circumstances.

Although there are plans to launch it in the United States and the European Union, it is worth noting that molotinib has not yet been launched in the Chinese market. This means that patients in China still need to rely on other treatment options, especially when facing the complex disease of myelofibrosis.