Shots:

• The approval is based on P-I/II SPRINT study assessing Koselugo (bid) as monothx. in pediatric patients aged ≥2yrs. with NF1-related inoperable PNs. The trial was sponsored by NCI CTEP- conducted under a research and development agreement between NCI and AstraZeneca with additional support from NTAP
• The P-I/II SPRINT study results demonstrated 66% ORR in pediatric patients with NF1 PN. The two companies jointly develop & commercialize Koselugo globally and have submitted an MAA to EMA in Q1’20
• Koselugo is a MEK1/2 inhibitor and has received the US FDA’s BT designation in Apr’2019- RPD in Dec’2019- ODD in Feb’2018- EMA’s ODD in Aug’2018 and Swissmedic’s ODD in Dec’2018 for the treatment of pediatric patients with NF1 PN

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Ref: AstraZeneca | Image: AstraZeneca