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AstraZeneca PLC (NASDAQ:AZN) announced Monday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended Koselugo (selumetinib) for approval in the European Union for the treatment of symptomatic, inoperable plexiform neurofibromas in adults with neurofibromatosis type 1 (NF1).
The recommendation is based on results from the KOMET Phase III trial, which included 145 adults with NF1 from 13 countries. The trial showed a statistically significant objective response rate of 20% (14 out of 71 patients, 95% CI:11.2, 30.9) for those treated with Koselugo, compared to 5% (4 out of 74 patients, 95% CI:1.5, 13.3; p=0.01) for those receiving placebo by cycle 16.
Koselugo is an oral, selective MEK inhibitor. The KOMET trial was the largest and only placebo-controlled, double-blind global Phase III study in this patient population, according to the company’s statement. The safety profile of Koselugo in the trial was consistent with its established use in pediatric patients.
NF1 is a rare, progressive genetic disorder that can lead to the development of plexiform neurofibromas, which may cause pain, disfigurement, and muscle weakness. Up to 50% of people with NF1 may develop these non-malignant tumors.
Koselugo is already approved in the US, EU, Japan, China, and other countries for certain pediatric patients with NF1 who have symptomatic, inoperable plexiform neurofibromas. It has been recently approved in Japan and other countries for use in adult patients with these tumors, and additional regulatory reviews are ongoing.
The information in this article is based on a press release statement included in AstraZeneca’s filing with the US Securities and Exchange Commission.
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