FDA News

Benralizumab auto-injector pen receives FDA approval for severe asthma

AstraZeneca announced it has received FDA approval for the self-administration of benralizumab in a prefilled, single-use auto-injector pen for patients with severe eosinophilic asthma, according to a company press release.

The benralizumab auto-injector (Fasenra Pen) enables patients and caregivers to administer the medicine using a two-step process. The device includes a viewing window and audible clicks at the start and end of the injection to guide patients with successful administration.

The FDA’s approval of the benralizumab prefilled auto-injector is based on data from the phase 3 GRECO and phase 1 AMES trials.

In the multicenter, open-label, 28-week GRECO trial, researchers evaluated the patient- or caregiver-reported functionality, performance and reliability of a prefilled auto-injector device with a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks in the clinic and in an at-home setting in 120 adults with severe uncontrolled asthma. Nearly all (97%) of at-home administrations given by patients or caregivers were successful at week 12 and week 16, and 96% of the returned devices used to administer the drug at home were evaluated as being functional at weeks 12 and 16, according to the release.

AstraZeneca announced it has received FDA approval for the self-administration of benralizumab in a prefilled, single-use auto-injector pen for patients with severe eosinophilic asthma, according to a company press release.
Source: Shutterstock

In the multicenter, randomized, open-label, parallel-group AMES trial, researchers compared the pharmacokinetic exposure after a single, subcutaneous administration of benralizumab 30 mg using prefilled syringes or prefilled auto-injector devices. They found pharmacokinetic exposure to benralizumab was comparable after administration with the prefilled syringe or prefilled auto-injector and that eosinophils were rapidly depleted in both patient groups, according to the release.

The safety profile in both trials was similar to that observed in previous trials.

Benralizumab self-administration and the benralizumab prefilled auto-injector are also approved in the EU, and benralizumab is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the U.S., EU, Japan and other countries. The drug is not approved for treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

AstraZeneca announced it has received FDA approval for the self-administration of benralizumab in a prefilled, single-use auto-injector pen for patients with severe eosinophilic asthma, according to a company press release.

The benralizumab auto-injector (Fasenra Pen) enables patients and caregivers to administer the medicine using a two-step process. The device includes a viewing window and audible clicks at the start and end of the injection to guide patients with successful administration.

The FDA’s approval of the benralizumab prefilled auto-injector is based on data from the phase 3 GRECO and phase 1 AMES trials.

In the multicenter, open-label, 28-week GRECO trial, researchers evaluated the patient- or caregiver-reported functionality, performance and reliability of a prefilled auto-injector device with a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks in the clinic and in an at-home setting in 120 adults with severe uncontrolled asthma. Nearly all (97%) of at-home administrations given by patients or caregivers were successful at week 12 and week 16, and 96% of the returned devices used to administer the drug at home were evaluated as being functional at weeks 12 and 16, according to the release.

AstraZeneca announced it has received FDA approval for the self-administration of benralizumab in a prefilled, single-use auto-injector pen for patients with severe eosinophilic asthma, according to a company press release.
Source: Shutterstock

In the multicenter, randomized, open-label, parallel-group AMES trial, researchers compared the pharmacokinetic exposure after a single, subcutaneous administration of benralizumab 30 mg using prefilled syringes or prefilled auto-injector devices. They found pharmacokinetic exposure to benralizumab was comparable after administration with the prefilled syringe or prefilled auto-injector and that eosinophils were rapidly depleted in both patient groups, according to the release.

The safety profile in both trials was similar to that observed in previous trials.

Benralizumab self-administration and the benralizumab prefilled auto-injector are also approved in the EU, and benralizumab is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the U.S., EU, Japan and other countries. The drug is not approved for treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.