AstraZeneca’s Selumetinib Receives the US FDA’s Breakthrough Therapy Designation for Neurofibromatosis Type 1

 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

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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