AstraZeneca and its global biologics research and development arm, MedImmune, have announced that the US Food and Drug Administration has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
AstraZeneca chief executive Pascal Soriot said: 'We're excited to offer Fasenra as a new precision biologic to help improve the lives of severe asthma patients whose disease is driven by eosinophilic inflammation.
'This is the first approval from our respiratory biologics portfolio and the latest in a series of significant milestones for our company as we deliver on our pipeline-driven transformation.'
AstraZeneca said FDA approval was based on results from the WINDWARD programme, including the pivotal phase III exacerbation trials, SIROCCO and CALIMA, and the phase III oral corticosteroid (OCS)-sparing trial, ZONDA.
At 9:35am: (LON:AZN) AstraZeneca PLC share price was +40.75p at 5000.25p