Type of information: Granting of a Market Authorisation in Japan
Product name: Fasenra®
Therapeutic area: Allergic diseases – Inflammatory diseases – Respiratory diseases
- monoclonal antibody. Benralizumab is a monoclonal antibody directed at the alpha subunit of the interleukin-5 receptor (IL-5Ralpha) that depletes eosinophils, a key target cell in inflammatory respiratory disease. Emerging evidence shows that for patients with elevated eosinophil counts, treatment with an IL-5 inhibitor in addition to guideline-based strategies may improve their asthma control and decrease the frequency of asthma attacks. The anti-eosinophil, humanised monoclonal antibody benralizumab binds to the human interleukin-5 receptor expressed on the surface of eosinophils and basophils. This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity, and therefore, reduces eosinophilic inflammation.
- This antibody is in-licensed from BioWa, a wholly-owned subsidiary of Kyowa Hakko Kirin. Under the exclusive license agreement, Kyowa Hakko Kirin/BioWa have exclusive development and commercialisation rights for benralizumab in Japan and certain countries in Asia. AstraZeneca has exclusive rights for benralizumab in all other countries including the US and Europe. BioWa is eligible for milestone payments and royalties related to the development and commercialisation of benralizumab in those countries.
Company: AstraZeneca (UK)
- add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
- add-on maintenance treatment in adult patients with severe
eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting Beta-agonists
- • On January 19, 2018, AstraZeneca announced that the Japanese Ministry of Health, Labour and Welfare has approved Fasenra® (benralizumab) as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite treatment with high-dose inhaled corticosteroid and other asthma controllers.
- The approval is based on the results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III oral corticosteroid (OCS)-sparing trial, ZONDA.
- Fasenra® will be available as a fixed-dose subcutaneous injection in a prefilled syringe administered once every four weeks for the first three doses, and then once every eight weeks thereafter.
- • On January 10, 2018, AstraZeneca announced that the European Commission has approved Fasenra® (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.
- • On November 14, 2017, the FDA has approved Fasenra® (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. The approval is based on results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III oral corticosteroid (OCS)-sparing trial, ZONDA. Results for the 8-week benralizumab dosing regimen from these trials showed:
- - Up to 51% reduction in the annual asthma exacerbation rate (AAER) versus placebo
- - Significant improvement in lung function as measured by forced expiratory volume in one second (FEV1) of up to 159mL versus placebo. Differences were seen as early as 4 weeks after the first dose, providing an early indication of effectiveness
- - 75% median reduction in daily OCS use and discontinuation of OCS use in 52% of eligible patients
- Fasenra® is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours. Eosinophils are a type of white blood cell that are a normal part of the body's immune system. Elevated levels of eosinophils, seen in about half of severe asthma patients, impact airway inflammation and airway hyper-responsiveness, resulting in increased asthma severity and symptoms, decreased lung function and increased risk of exacerbations.
- Fasenra® binds directly to the IL-5? receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis (programmed cell death). Fasenra will be available as a once every 8-week fixed-dose subcutaneous injection via a prefilled syringe.
- • On November 9, 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a marketing authorisation for Fasenra®,
intended for the treatment of severe eosinophilic asthma.
- Fasenra® will be available as 30-mg solution for injection in pre-filled syringes.
- The benefits with Fasenra® are its ability to induce depletion of eosinophils in the blood and lung. This leads to significant reductions in annual exacerbation rates compared with placebo, especially in patients with more than 300 eosinophils/microlitre of blood pre-treatment . The most frequent side effects are headache (8%) and pharyngitis (3%).
The full indication is: “Fasenra® is indicated as an add-on maintenance treatment in adult patients with severe
eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-11-14
UE authorization: 2018-01-08
Favourable opinion UE: 2017-11-09
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: