FDA grants AstraZeneca's Fasenra orphan drug designation

(Sharecast News) - AstraZeneca said on Wednesday that the US Food and Drug Administration has granted orphan drug designation (ODD) to Fasenra for the treatment of hypereosinophilic syndrome (HES), a group of rare and potentially fatal disorders that can cause progressive damage to any organ in the body.The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.In a Phase II clinical trial of Fasenra conducted by the United States National Institutes of Health in collaboration with AstraZeneca - the results of which are expected to be published later this year - Fasenra depleted blood eosinophils at week 12 compared with placebo, the primary endpoint of the trial.Mene Pangalos, executive vice president, R&D BioPharmaceuticals, said: "In patients with hypereosinophilic syndrome, high levels of eosinophils contribute to a range of debilitating symptoms and can even lead to life-threatening organ damage. Based on results from the Phase II trial, we believe Fasenra has the potential to address critical unmet medical needs in patients living with hypereosinophilic syndrome."AstraZeneca's Fasenra is currently approved as an add-on maintenance treatment for severe, eosinophilic asthma in the US, EU, Japan and a number of other countries.At 1015 GMT, the shares were down 1% to 5,655p.