On 13 April 2020 Astra Zeneca and MSD Inc. announced that the US Food and Drug Administration (FDA) had approved the MEK-inhibitor Koselugo (selumetinib) for treating inoperable plexiform neurofibromas in patients with neurofibromatosis type 1 (two years of age and older).
This is the first regulatory approval of a medicine for the treatment of plexiform neurofibromas in neurofibromatosis type 1. Koselugo is developed and commercialized jointly by AstraZeneca and Merck.
It must be taken into account that serious adverse reactions can occur with this medicine (including cardiomyopathy, ocular toxicity, gastrointestinal toxicity, skin toxicity, and other).
Highlights of prescribing information can be found here.
According to the media sources, approval for Koselugo in Europe is expected to follow, with a marketing authorization application submitted to the European Medicines Agency (EMA) in Q1 2020.
NFPU on behalf of its members highly appreciates the efforts of Astra Zeneca and MSD Inc. and congratulates them on this breakthrough!