AstraZeneca (AZN) said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Koselugo in the European Union to treat neurofibromatosis type 1.
The UK pharmaceutical company said the decision was based on a phase 3 trial that showed "a statistically significant objective response rate."
Neurofibromatosis type 1 is a rare, progressive, genetic condition, which is usually diagnosed in early childhood, AstraZeneca said.
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