Degarelix Accord: Pending EC decision

On July 20, 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for the medicinal product Degarelix Accord, intended for the treatment of hormone-dependent prostate cancer. The applicant for this medicinal product is Accord Healthcare S.L.U.

Degarelix Accord will be available as an 80 mg and 120 mg powder and solvent for a solution for injection. The active substance of Degarelix Accord is degarelix acetate, a gonadotropin-releasing hormone receptor antagonist (ATC code: L02BX02). Degarelix binds to receptors in the pituitary gland, resulting in decreased secretion of luteinizing hormone and follicle-stimulating hormone, thereby reducing the secretion of testosterone by the testes, which slows down the growth of prostate cancer cells.

Degarelix Accord is a generic version of Firmagon, which has been authorized in the EU since February 17, 2009. Studies have demonstrated the satisfactory quality of Degarelix Accord and its bioequivalence to the reference product Firmagon. A bioequivalence study versus the reference product Firmagon was not required because of the qualitative and quantitative compositions and the nature and behavior of the products. A question and answer document on generic medicines can be found here.

The full indication is: Degarelix Accord is a gonadotropin-releasing hormone (GnRH) antagonist indicated for:

  1. Treatment of adult male patients with advanced hormone-dependent prostate cancer.
  2. Treatment of high-risk localized and locally advanced hormone-dependent prostate cancer in combination with radiotherapy.
  3. Neo-adjuvant treatment prior to radiotherapy in patients with high-risk localized or locally advanced hormone-dependent prostate cancer.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

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