Benralizumab

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Benralizumab
Mass / length primary structure 146 054.0  Da
Identifier
External IDs
Drug information
ATC code R03 DX10
DrugBank DB12023
Drug class Monoclonal Antibodies , Antiasthmatics

Benralizumab is a monoclonal antibody (humanized, from mouse cells) that is used to treat severe eosinophilic asthma .

pharmacology

In eosinophilic asthma, there is an increased number of eosinophilic granulocytes in the blood. These blood cells release interleukins , which in turn are involved in the inflammatory process in the lungs.

Benralizumab binds specifically and with high affinity to the interleukin-5 receptor (subunit IL-5Rα) of eosinophilic granulocytes and basophilic granulocytes and leads to apoptosis of affected cells (antibody-dependent cell-mediated cytotoxicity). The asthmatic inflammatory reaction is subsequently alleviated.

The plasma half-life is approximately 15 days.

Side effects

Common side effects can include:

  • a headache
  • Pharyngitis
  • local reactions at the injection site
  • Pyrexia
  • Hypersensitivity reactions

Finished medicinal products

AstraZeneca sells benralizumab 30 mg in the form of a pre-filled syringe for subcutaneous administration under the trade name Fasenra . Fasenra was approved in the USA in 2017. Approval for the European Union and Switzerland followed in 2018.

In the pharmaceutical newspaper , the launch of Fasenra was rated as a step innovation.

Early benefit assessment

In Germany, since 2011, newly approved drugs with new active ingredients must be subjected to an " early benefit assessment " by the Federal Joint Committee (G-BA) in accordance with Section 35a SGB ​​V if the pharmaceutical manufacturer wants to achieve a higher sales price than just the fixed amount . Only if there is an additional benefit can the pharmaceutical manufacturer negotiate a price with the umbrella association of statutory health insurance companies. The dossier evaluations, on the basis of which the G-BA makes its decisions, are created by the Institute for Quality and Efficiency in Health Care (IQWiG) .

In 2018, benralizumab as an add-on maintenance therapy in adults with severe eosinophilic asthma, which is inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta agonists, was compared with a patient-specific escalation of therapy. According to the G-BA resolution, an additional benefit has not been proven for those affected who have not yet exhausted further options for therapy escalation. If the other possibilities of therapy escalation have already been exhausted, according to the G-BA there is a hint of a minor additional benefit.

Individual evidence

  1. ↑ Teva: Eosinophilic Asthma ( Memento from October 22, 2018 in the Internet Archive ) (accessed October 21, 2018).
  2. ↑ Drugs benralizumab | Fasenra® | 28 | 2018 .
  3. ↑ A18-11 Benralizumab (asthma) - Benefit assessment according to Section 35a SGB V ; Accessed March 24, 2020.
  4. ↑ A18-42 Benralizumab (asthma) - Addendum to Commission A18-11 ; Accessed March 24, 2020.
  5. ↑ Benefit assessment procedure for the active ingredient benralizumab (bronchial asthma) ; Accessed March 24, 2020.

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