AstraZeneca PLC on Tuesday announced that China’s National Medical Products Association has approved benralizumab to treat patients aged 12 and older with severe eosinophilic asthma.
The Cambridge, England-based biopharmaceutical company said the approval for benralizumab, brand name Fasenra, is based on results from the Miracle phase 3 trial.
During the Miracle study, AstraZeneca said, Fasenra achieved a statistically significant and clinically meaningful 74% reduction in patients’ annualised asthma exacerbation rates.
‘Fasenra met all primary and key secondary endpoints in the trial, demonstrating improvements in lung function and asthma symptom control,’ AstraZeneca added.
The company said around 3 million people in China are estimated to have severe eosinophilic asthma but that misdiagnosis and undertreatment are both common, and treatment options are currently limited.
‘Today’s approval is an important step forward in the treatment of severe asthma in China, which affects millions of patients,’ commented Ruud Dobber, executive vice president of Astra’s BioPharmaceuticals business unit.
Fasenra, AstraZeneca noted, is currently approved as an add-on maintenance SEA treatment in over 80 countries.
Shares in AstraZeneca were trading 0.1% higher at 13,058.00 pence on Tuesday morning in London.
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