AstraZeneca PLC (LON:AZN) has been given US clearance for its self-administered pen version of severe asthma treatment Fasenra, one of its fastest-growing drugs.
Self-administrated and pen variations of Fasenra are already approved in Europe and as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and elsewhere.
Fasenra sales surged 244% in its latest quarter to US$296mln as it became the preferred novel-biologic medicine for the treatment of severe 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 GRECO trial is to measure a fixed-dose administered every four weeks in clinic and in an at‑home setting in 120 adults with severe uncontrolled asthma.
Nearly all (96%) of the returned pre-filled auto-injector devices used to administer Fasenra at home were evaluated as being functional at week 12 and week 16.