AstraZeneca’s Koselugo (selumetinib) Receives the NMPA’s Approval for the Treatment of Rare Genetic Disorder in Paediatric Patients
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- The NMPA has approved Koselugo for symptomatic, inoperable PN in paediatric patients aged ≥3yrs. with NF1. The approval was based on the P-II trial (SPRINT Stratum 1) evaluating Koselugo as monotx while the trial was sponsored by NCI CTEP & was conducted under a cooperative R&D agreement b/w NCI & AstraZeneca with additional support from NTAP
- The results showed a reduction in the size of inoperable tumors, ORR of 66% (33 out of 50 patients confirmed PR). The results were published in the NEJM
- Koselugo was approved in the US, EU, Japan & multiple other countries for NF1 & symptomatic, inoperable PNs. The therapy also received ODD in the US, EU, Russia, Switzerland, South Korea, Taiwan, Japan & Australia
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca and MSD's Koselugo (selumetinib) Receive the EU's Approval for Neurofibromatosis Type 1 and Plexiform Neurofibromas
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
