US FDA approved new drug Fasenra that contains active pharmaceutical ingredient benralizumab which is monoclonal antibody for the treatment of patients with severe asthma having eosinophilic phenotype. US FDA approved this drug as add-on maintenance therapy in the treatment of severe
asthma. US FDA also instructed about this drug usage limitation means that it is not for treatment of other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus.
Asthma is a chronic disease that causes inflammation in the airways of the lungs. During an asthma attack, airways become narrow making it hard to breathe. Severe asthma attacks can lead to asthma-related hospitalizations because these attacks can be serious and even life-threatening.
According to the Centers for Disease Control and Prevention, as of 2013, more than 22 million people in the U.S. have asthma, and there are more than 400,000 asthma-related hospitalizations each year.
Benralizumab is a humanized afucosylated, monoclonal antibody (IgG1, kappa) that directly binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with a dissociation constant of 11 pM. The IL-5 receptor is expressed on the surface of eosinophils and basophils. In an in vitro setting, the absence of fucose in the Fc domain of benralizumab facilitates binding (45.5 nM) to FcɣRIII receptors on immune effectors cells, such as natural killer (NK) cells, leading to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC).
Fasenra/benralizumab Side effects
Following side effects were observed during clinical trials of this drug
- Skin irritability
Fasenra/benralizumab Uses/Prescribing Information
This drug is approved for the treatment of patients with severe asthma having eosinophilic phenotype. US FDA approved this drug as add-on maintenance therapy in the treatment of severeasthma. US FDA also instructed about this drug usage limitation means that it is not for treatment of other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus.
This drug is formulated in a single-dose prefilled syringe with potency of 30 mg/mL solution. Recommended dose is 30 mg every 4 weeks for the first 3 doses, followed by once every 8 weeks thereafter via subcutaneous injection.
This drug is administered by your healthcare practitioner (HCP), which usually means:
- It may comes under special items category.
- You cannot fill this prescription in a regular pharmacy. Your doctor, hospital, or clinic will provide this medication because of possible complications or other issues.
- This drug is likely to be covered under your medical benefit if you have insurance.