AstraZeneca’s Selumetinib Receives the US FDA’s Breakthrough Therapy Designation for Neurofibromatosis Type 1
AstraZeneca to Divests Global Rights of Movantik (naloxegol) to RedHill Biopharma
Shots:
- The BT Designation follows the P-II SPRINT trial assessing selumetinib as a monothx (PO) in paediatric patients, aged three years or older with inoperable NF1-related PN
- The ninth BT designation is granted to the AstraZeneca for the MEK 1/2 inhibitor and the results will further lead to expedited regulatory review
- Selumetinib is a MEK 1/2 inhibitor also received the US FDA’s ODD to treat NF1 in Feb 2018 and the European Medicines Agency in Aug 2018. In 2017, AstraZeneca and MSD signed a co-development and co-commercialisation agreement for selumetinib
Click here to read full press release/ article | Ref: AstraZeneca | Image: StraitTimes
