Asthma drug can now be self-administered via pen
Drug is the only respiratory therapy that can be given at home every 8 weeks.
Mina Makar, RPh
FDA approved the self-administration of benralizumab (Fasenra, AstraZeneca) for patients with severe eosinophilic asthma. Patients and doctors can now use the medication via a pre-filled, single-use auto injector (Fasenra Pen).
“Fasenra is the only respiratory biologic that can be given in a doctor’s office or at home every 8 weeks, after the initial loading-dose period. This approval is important because healthcare professionals and patients now have another option to personalize their treatment approach to help meet their needs and help fit their lifestyle,” Mina Makar, RPh, senior vice president of US Respiratory at AstraZeneca, told FormularyWatch.
Related: Generic asthma inhaler gets FDA nod
Fasenra self-administration and the Fasenra Pen are also approved in the European Union (EU). Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries.
Makar expects the Fasenra pen to be available in the US in the “short term.”
While the wholesale acquisition cost of the medication is $4,895.74 per 30 mg/mL, “it’s important to understand that list price may not be reflective of the cost for Fasenra. Out-of-pocket costs are determined by insurance type,” Makar said.
Related: Self-injectable respiratory medication opens doors for patients with severe asthma
AstraZeneca is “committed to providing assistance if a patient can’t afford Fasenra, and we offer Access 360 to provide a range of support services including reimbursement support, affordability programs if you are eligible, nursing support for Fasenra questions, and ongoing education,” Makar said. “For those with private insurance, they may be eligible for the Fasenra Savings Program regardless of coverage and pay as little as $0 for Fasenra and as little as $0 for its injection administration.”
The Fasenra Pen enables patients and caregivers to administer the medicine via a simple two-step process, AstraZeneca said in a statement. The device includes a viewing window and audible clicks at the start and end of the injection to guide patients with successful administration.
Fasenra is also in development for severe nasal polyposis, other eosinophilic diseases, and chronic obstructive pulmonary disease (COPD).
Read more: Biologic gets asthma indication
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
Read More
