Will Selumetinib be launched in 2023?

The U.S. Food and Drug Administration (FDA) approved applications for priority review, breakthrough therapy, and orphan drug designation for selumetinib, which was granted rare pediatric disease designation for the treatment of children. Neurofibromatosis type 1 (NF1) and a rare pediatric disease priority review voucher. In April 2020, selumetinib was approved by the FDA to treat children with neurofibromatosis type 1. It is the first drug approved in the United States to treat this rare disease and is sold under the trade name Koselugo.

Selumetinib has been shown by the European Medicines Agency (EMA) to be effective in shrinking tumors in children aged 3 years and older. Due to the rarity of the disease, the number of children participating in the trial was small. Although data on safety are limited, they suggest that the side effects of selumetinib are manageable and that its benefits outweigh its risks. Therefore inJune 2021 the European Medicines Agency decided that selumetinib can be authorized for use in the EU.

Selumetinib The original drug has been approved by the State Food and Drug Administration in April 2023 for domestic marketing, but it has not yet entered the scope of medical insurance. The price of each box of 10mg*60 tablets may be more than 20,000 yuan, which is relatively expensive. Selumetiniboriginal drug marketed overseas, specifications10mg*60 capsules per box may cost more than RMB 50,000 (the price may fluctuate due to exchange rates). The ingredients of the original selumetinib sold domestically and abroad are basically the same. There is currently no generic version of selumetinib produced and marketed. For more drug information and specific prices, please consult the medical consultant of Yaode.