AstraZeneca PLC on Monday welcomed approval in the European Union of Fasenra for the treatment of eosinophilic granulomatosis with polyangiitis.
EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs. It affects people with a history of allergies or asthma causing inflammation in blood vessels and small masses that infiltrate tissues, especially lungs.
AstraZeneca, a Cambridge, England-based pharmaceuticals firm, said the approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on positive results from the Mandara Phase III trial, published in the New England Journal of Medicine.
Mandara was the first head-to-head non-inferiority trial of biologics in patients with EGPA.
In the trial, nearly 60% of Fasenra-treated patients achieved remission. The safety and tolerability profile for Fasenra in the Mandara trial was consistent with the known profile of the medicine.
Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AstraZeneca said: ‘Today’s approval of Fasenra...is a positive step forward for patients with EGPA. Fasenra has been a well-established treatment for many years in thousands of people with severe eosinophilic asthma and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe.’
Shares in AstraZeneca slipped 0.5% at 11,548.00 pence each in London on Monday morning. The wider FTSE 100 index was up 0.2%.
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