Fasenra (benralizumab) is a new 30 mg subcutaneous injection being developed by AstraZeneca. Fasenra has been shown to help patients with severe asthma cut back on oral steroids. Fasenra is the trade/brand name of the monoclonal antibody, Benralizumab. Benralizumab (Fasenra) binds to the alpha chain of the IL-5 receptor present on both eosinophils and basophils, resulting in depletion of these key inflammatory cells. This would be the 3rd monoclonal antibody that targets IL-5 binding. Nucala (mepolizumab) and Cinqair (reslizumab) have already been launched and Fasenra would be directly competing with them for patients with severe eosinophilic asthma. Clinical trials dosed Fasenra every 8 weeks which would be an advantage over Nucala and Cinqair which are dosed every 4 weeks.
Fasenra is expected to launch mid-November 2017. It is also being studied for COPD (Chronic Obstructive Pulmonary Disease), but results have not been as promising as its been for asthma. Blocking the IL-5 Receptor (CD-125), depletes the blood and airway of eosinophils, which would make it ideal for eosinophilic asthma. Eosinophils are the biological effector cells that impact airway inflammation and airway hyper-responsiveness in approximately 50% of asthma patients, which leads to increased asthma symptoms, impaired lung function and more frequent exacerbations. Eosinophil mediated inflammation is associated with progressive airway damage. Patients who had higher eosinophil counts and more severe asthma seemed to benefit most from Fasenra. Patients who were on oral steroids and nasal polyps also showed a greater magnitude of improvement on benralizumab.
A phase 3 study, showed patients on Fasenra were able to reduce their oral steroid dose compared to patients who took placebo. It also reduced the exacerbation rate by 70% and ER/hospitalization rate by 93% of patients who had severe uncontrolled eosinophilic asthma.
Being the 3rd monoclonal antibody targeting IL-5 binding (Nucala and Cinqair bind IL-5 directly) and the growth of eosinophils, a big question for asthma specialists is which medication do you use? Between Nucala, Cinqair and Fasenra, which one works best for severe asthma? Xolair is another monoclonal antibody for severe asthma, but it targets IgE, the “allergy antibody” in the blood. It is indicated for allergic asthma and for patients who have allergies to perennial allergens (e.g dust, mold, dog, cat, cockroach). So there will be 4 monoclonal antibody medications out soon and more are coming.
Allergy Biologics, Past, Present and Future…
Asthma Biologics, what is their role in asthma?
There are no head to head studies comparing Fasenra, Nucala and Cinqair, and likely there will never be. It would be up to the physician and patient to discuss the pros and cons of each medication to determine which treatment course is best. The price tag for these medications are somewhere between $2000-3000/month before insurance. Insurance companies have strict criteria before approving these medications. What kind of insurance coverage a patient has also may also determine which of these medications a patient with severe eosinophilic asthma needs to try first. AstraZeneca will most likely have patient support programs to help with copays for those whose insurances give only partial coverage. Other medications that AstraZeneca uses for milder or more moderate cases of asthma include, Accolate (zafirlukast), Pulmicort (budesonide) and Symbicort (budesonide/formoterol).
As always if your asthma is not well controlled, speak to your asthma/allergy doctor about what options are best for you.
New Asthma Drug Nucala (Mepolizumab) for Severe Eosinophilic Asthma
Cinqair (Reslizumab) for Eosinophil Disorders (formerly Cinquil)
Pivotal Studies: In a study called ZONDA, Fasenra (benralizumab) was four times more likely to reduce oral steroid dose compared to placebo in adults with severe eosinophilic asthma. In the BISE trial, Fasenra also reduced exacerbation rates in patients with mild to moderate asthma, although it had no significant change on FEV1 in their spirometry results. The cutoff point for the eosinophil count in the study was 300 cells/microliter.
Fasenra Dosing: When Fasenra is released, its dosing will be different from the other monthly biologic asthma medications, Nucala, Cinqair and Xolair (can be every 2 weeks). Fasenra will be dosed every 4 weeks for the first 3 months only (30mg), then it will be given every 8 weeks as a maintenance dose. It comes in a pre-mixed syringe, so no reconstitution of the medication will be necessary.
Update 11/15/2017: Fasenra has been officially approved today for add-on maintenance treatment for asthmatic patients aged 12 years and older. Common side effects are headache and pharyngitis. Hypersensitivity reactions of anaphylaxis have occurred within hours of administration and sometimes even delayed onset (days). Most likely there will be a waiting period in the office after administration in a doctors office and all patients prescribed Fasenra will need to have injectable epinephrine (i.e. Epipen) on hand.
Fasenra cost: Before any rebates and insurance, the cost for the first year of treatment is approximately $38,000/year. After the first year, the maintenance year will require approximately 6-7 shots the whole year and the cost of that would be between $28,000 to $33,000.