AZN Wins FDA Nod for Expanded Use of Rare Disease Drug, Koselugo

Key Takeaways AstraZeneca gained FDA approval to extend Koselugo use to adult NF1 patients with symptomatic, inoperable PN.Koselugo's label was also recently expanded in the EU, Japan and other countries, with more reviews ongoing.AZN's KOMET study showed a 20% overall response rate for Koselugo versus 5% with placebo by cycle 16.AstraZeneca (AZN) announced that the FDA has approved its oral, selective MEK inhibitor, Koselugo (selumetinib), for expanded use. The drug is now indicated to treat symptomatic, i ...