4th Oct 2019 07:59
(Alliance News) - AstraZeneca PLC on Friday said the US has approved self-administration of Fasenra in the form of the Fasenra Pen.
The pen is a "pre-filled, single-use auto-injector" form of asthma drug Fasenra, meaning patients taking the drug can inject the medication themselves at home instead of going to the doctor for an injection.
Approval for the Fasenra Pen was based on that phase 3 Greco trial and phase 1 Ames trial, which showed that the Fasenra Pen's safety and tolerability was consistent with the drug's existing profile.
Fasenra has been approved as an add-on maintenance treatment for severe eosinophilic asthma, a type of asthma where the patient has very high levels of while blood cells called eosinophils, which cause inflammation in the airways.
Mene Pangalos, executive vice president of BioPharmaceuticals Research & Development at AstraZeneca, said: "Fasenra is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period. Today's news means we 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 pen is also ready approved in the EU. Fasenra is currently approves in the US, EU, and Japan, as well as other countries, as an add-on maintenance treatment for severe eosinophilic asthma.
By Anna Farley; [email protected]
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