Shots:

• The ODD designation follows P-I/II SPRINT Stratum 1 study assessing Selumetinib (bid) as monothx. in pediatric patients with NF1-related inoperable PNs
• The P-I/II SPRINT Stratum 1 study demonstrated a reduction in the size of tumors with 66% ORR in children. AstraZeneca and MSD are co-developing and co-commercializing selumetinib which received the US FDA’s approval in Apr’2020 under the brand name “Koselugo”
• Selumetinib is a MEK1/2 inhibitor and has received the US FDA’s BT & RPD designation in 2019- ODD in 2018- and EU and Swissmedic’s ODD in 2018 for pediatric patients with NF1 PN. The MAA for the therapy is under EMA’s reviews with other ongoing global regulatory submissions

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Ref: AstraZeneca | Image: Business Journal