AstraZeneca: FDA approves Fasenra for severe asthma.
(CercleFinance.com) - AstraZeneca said on Wednesday that the US Food and Drug Administration (FDA) has approved Fasenra for the add-on maintenance treatment of patients with severe asthma.
The biopharmaceutical firm, which is in the midst of a "pipeline-driven transformation," said that the FDA's approval is based on results from a phase III trial showing up to a 51% reduction in asthma exacerbation versus placebo.
Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also adopted a positive opinion, recommending the drug's marketing authorisation.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The biopharmaceutical firm, which is in the midst of a "pipeline-driven transformation," said that the FDA's approval is based on results from a phase III trial showing up to a 51% reduction in asthma exacerbation versus placebo.
Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also adopted a positive opinion, recommending the drug's marketing authorisation.
Copyright (c) 2017 CercleFinance.com. All rights reserved.