Dupilumab

from Wikipedia, the free encyclopedia
Dupilumab
Identifier
External IDs
Drug information
ATC code D11 AH05
DrugBank DB12159

Dupilumab is a monoclonal antibody that is used as a drug (trade name Dupixent ; manufacturer Sanofi-Aventis ) for the treatment of atopic dermatitis (neurodermatitis). Dupilumab works by blocking the alpha chain of the interleukin-4 receptor (IL-4Ra, CD124) and thus two central cytokines of the Th2 immune response ( IL-4 , IL-13 ). It has shown promising results in two phase 3 studies . It is used by subcutaneous injection.

Admission status

  • EU: In September 2017, dupilumab was approved in the EU for the treatment of atopic eczema ( neurodermatitis ) by the European Commission . Approval for severe asthma (with eosinophilia and / or FeNO increase) has been in place since May 2019
  • USA: The American FDA approved dupilumab in March 2017.

The approval is based u. a. on the studies SOLO 1 and SOLO 2 .

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) .

The first early benefit assessment in 2017 dealt with the treatment of moderate to severe atopic dermatitis in adults for whom systemic therapy is an option. According to the G-BA decision, there is an indication of a considerable additional benefit compared to the ACT. After an extension of the approval, it was investigated in 2019 whether dupilumab also has an additional benefit as an add-on maintenance therapy in adults and adolescents from 12 years of age whose severe asthma with type 2 inflammation is characterized by an increased number of eosinophils in the blood and / or increased FeNO and is inadequately controlled despite high-dose inhaled corticosteroids and another drug used as maintenance therapy. According to the G-BA resolution, an additional benefit compared to a patient-specific escalation of therapy taking into account the previous therapy has not been proven. In a third study, dupilumab was evaluated for the treatment of moderate to severe atopic dermatitis in adolescents aged 12 to <18 years who are eligible for systemic therapy. According to the G-BA decision, there is a hint of a non-quantifiable additional benefit compared to the appropriate comparator therapy, a patient-individually optimized therapy regimen consisting of topical and systemic therapy depending on the severity of the disease and taking into account the previous therapy.

Therapy costs

According to The New York Times , the treatment costs are in the US at 37,000 US dollars / year. In Germany, the treatment costs around 22,000 EUR per year.

Trade names

Dupixent (USA)

Individual evidence

  1. ↑ New ATC / DDD classification; Implementation in the ATC / DDD (index: 2018) (PDF) WHO Collaborating Center for Drug Statistics Methodology; accessed on December 4, 2017.
  2. ↑ Atopic dermatitis: Dupilumab shines in phase 3 studies . In: Deutsches Ärzteblatt , October 4, 2016; Retrieved July 17, 2017.
  3. ↑ Dupixent / dupilumab , PM EMA: Dupixent - dupilumab Authorization details of September 27, 2017, accessed on October 26, 2017.
  4. ↑ Sanofi Aventis (Ed.): Specialist information Dupixent 300 mg .
  5. ↑ FDA approves new eczema drug Dupixent . Press release, FDA, March 28, 2017; Retrieved July 22, 2017.
  6. ↑ Eric L. Simpson et al .: Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis . In: New England Journal of Medicine . December 2016, doi : 10.1056 / NEJMoa1610020 .
  7. ↑ Philipp Kressirer: New active ingredient against neurodermatitis. In: IDW Informationsdienst Wissenschaft. idw-online.de, October 5, 2016, accessed on July 22, 2017 .
  8. ↑ A17-63 Dupilumab (atopic dermatitis) - Benefit assessment according to § 35a SGB V . iqwig.de; accessed on April 20, 2020.
  9. ↑ Benefit assessment procedure for the active ingredient dupilumab (atopic dermatitis) . g-ba.de; accessed on April 20, 2020.
  10. ↑ A19-74 Dupilumab (asthma) - Benefit assessment according to § 35a SGB V . iqwig.de; accessed on April 20, 2020.
  11. ↑ Benefit assessment procedure for the active ingredient dupilumab (new area of ​​application: bronchial asthma, ≥ 12 years) . g-ba.de; accessed on April 20, 2020.
  12. ↑ A19-75 Dupilumab (atopic dermatitis in adolescents) - Benefit assessment according to § 35a SGB V . iqwig.de; accessed on April 20, 2020.
  13. ↑ Benefit assessment procedure for the active ingredient dupilumab (new area of ​​application: atopic dermatitis, 12 to <18 years) . g-ba.de; accessed on April 20, 2020.
  14. ↑ Severe Eczema Drug Is Approved by FDA; Price Tag Is $ 37,000 a Year . In: The New York Times , March 28, 2017; Retrieved July 22, 2017.
  15. ↑ Dupixent 300 mg Inj.-Solution, ready-to-use. 2pcs. Bodfeld Apotheke, accessed on January 3, 2018 .