CHMP Issues Positive Opinion for Self-Administration of Fasenra

AstraZeneca has revealed in a July 1, 2019 press statement that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).

Additionally, the CHMP issued a positive opinion for a new delivery method of Fasenra as a pre-filled single-use auto-injector (the Fasenra pen). Both positive opinions will be added to the medicine’s product information in the European Union.

“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,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, in the press release. “We hope self-administration and the Fasenra pen will play important roles in helping physicians make treatment with biologic medicines accessible to more people with severe eosinophilic asthma.”

The CHMP’s positive opinion for Fasenra’s self-administration was supported by Phase III data from the DREGALE and GRECO trials and for the Fasenra pen through Phase I data from the AMES trial. Safety and tolerability of the therapy was found to be consistent with its known profile within the trials.

AstraZeneca has stated that it now anticipates a regulatory decision by the US Food and Drug Administration on the additional option and new delivery method of Fasenra in the second half of 2019.

Source: AstraZeneca