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AstraZeneca said the US Food and Drug Administration had approved the self-administration of the companys respiratory medication in a pre-filled pen.
The company said it can now offer Fasenra in an even more convenient way, giving US healthcare providers and patients the option of administering Fasenra at home or in a doctor's office, and making treatment more accessible to patients with severe eosinophilic asthma.
The approval was supported by data from the Phase III Greco trial and the Phase I AMES trial. The safety and tolerability of Fasenra in these trials were consistent with the established profile of the medicine, the company said.