Fasenra receives CHMP opinion for self-administration and injector pen
AstraZeneca's Fasenra (benralizumab) received a positive opinion from the EMA's CHMP for self-administration and a new pre-filled auto-injector pen in the EU.
AstraZeneca announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding options for self-administration of Fasenra (benralizumab) and the introduction of a new pre-filled, single-use auto-injector pen within the European Union.
The company anticipates a regulatory decision from the U.S. Food and Drug Administration (FDA) for self-administration and the new 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.
The new Fasenra pen allows patients and caregivers to administer the medication through a simple two-step process. The device includes a viewing window and audible cues to guide users through a successful injection. Safety and tolerability data from supporting trials are consistent with the medicine's known profile.
Fasenra is a biologic medicine targeting eosinophils, which was previously administered by healthcare professionals. The availability of self-administration and the auto-injector format is expected to enhance patient convenience and potentially broaden treatment access.