AstraZeneca announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to add a self-administration option for Fasenra (benralizumab) and a new delivery method as a pre-filled, single-use auto-injector (the Fasenra pen) to the medicine’s product information in the European Union.
The CHMP opinion can be implemented without the need for a European Commission decision due to the nature of the Type-II label variation.
The positive opinion for self-administration and the Fasenra pen is supported by the Phase III GREGALE and GRECO trials, and the Phase I AMES trial, respectively. The safety and tolerability of Fasenra in these trials were consistent with the known profile of the medicine.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
“Fasenra is the only respiratory biologic medicine that can be administered every eight weeks after the initial loading-dose period, and this positive opinion means we are closer to offering Fasenra in a way that is even more convenient for many patients. We hope self-administration and the Fasenrapen will play important roles in helping physicians make treatment with biologic medicines accessible to more people with severe eosinophilic asthma.”
AstraZeneca anticipates a regulatory decision by the US Food and Drug Administration (FDA) on self-administration and the new pre-filled, single-use auto-injector device in the second half of 2019. Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries.