AstraZeneca: FDA grants breakthrough therapy to selumetinib
(CercleFinance.com) - Anglo-Swedish drugmaker AstraZeneca said on Monday that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for experimental drug selumetinib for the treatment of type-1 neurofibromatosis, a rare and incurable genetic condition.
The FDA's decision has been based on Phase II data, testing selumetinib as an oral monotherapy in pediatric patients, aged three years or older, for this debilitating disease, which has no approved medications to date.
Selumetinib was granted orphan drug designation by the European Medicines Agency in August 2018.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
The FDA's decision has been based on Phase II data, testing selumetinib as an oral monotherapy in pediatric patients, aged three years or older, for this debilitating disease, which has no approved medications to date.
Selumetinib was granted orphan drug designation by the European Medicines Agency in August 2018.
Copyright (c) 2019 CercleFinance.com. All rights reserved.