The launch time and latest approval progress of Lemborexant in China

Lemborexant (trade name Dayvigo®) is a new dual orexin receptor antagonist (DORA), mainly used to treat insomnia in adults. By selectively inhibiting the orexin A and orexin B signaling pathways, leborexan can help patients fall asleep faster and stay asleep longer while maintaining natural sleep structure. In 2019, leborexan was officially approved for marketing in the United States, providing a new treatment option for insomnia patients and showing good clinical efficacy and tolerability.

According to the latest information, the original drug Lebraxen has been successfully launched in China, but it has not yet been included in the national medical insurance directory. This means that patients can purchase the drug through regular domestic hospitals or pharmacies, but they need to bear the full cost out of their own pocket. At present, domestic regulatory agencies have approved its marketing and allow its use in clinical use according to the instructions, but it has not yet carried out an evaluation of the medical insurance reimbursement policy or included it in the scope of reimbursement.

In overseas markets, especially Japan, the price of the original drug of Lebrasin is about about one thousand yuan. Currently, there are no generic drugs of Lebraxen on the market globally, so patients mainly rely on the supply of original drugs when obtaining drugs. This also results in some patients having a certain price burden. At the same time, when choosing overseas channels, they need to pay attention to formal qualifications and drug authenticity to ensure drug safety.

From the perspective of market trends, the domestic launch of Leborexan provides a new oral drug option for the treatment of insomnia, which is especially suitable for patients with refractory insomnia or those with poor tolerance to traditional sleeping pills. In the future, with the accumulation of clinical data and drug price adjustments, Lebraxant is expected to be included in the medical insurance system to reduce patients' medication burden. At the same time, with the progress of research and development and generic drugs, more affordable generic versions may appear in the future, providing patients with more accessible options. Clinically, doctors and patients still need to pay attention to the long-term efficacy, safety and risks of combined use with other central depressant drugs.

Reference link:https://www.drugs.com