LONDON (Alliance News) - AstraZeneca PLC on Wednesday said the US Food & Drug Administration has granted Orphan Drug Designation to Fasenra for the treatment of hypereosinophilic syndrome.
Fasenra is AstraZeneca's first respiratory biologic drug and is currently approved as an add-on maintenance treatment for severe, eosinophilic asthma in the US, EU, Japan and some other countries.
The FTSE 100-listed pharmaceutical company said a second phase of clinical trial of Fasenra for the treatment of hypereosinophilic syndrome has been conducted in collaboration with the US National Institutes of Heath, with results expected to be published later in 2019.
In the trial, Fasenra depleted blood eosinophils at week 12 compared with placebo, the primary endpoint of the trial, with evidence of eosinophil clearance in affected tissue at week 24.
"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," explained Mene Pangalos, executive vice president at Research & Development BioPharmaceuticals.
"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," added Pangalos.
Astrazeneca (AZN)
