Degarelix

Oncology· 110 cited findings· 1 source document

Company: Ferring A S

What the regulatory reviews say

Degarelix is a drug for which Marketing Authorisation was granted in Europe in February 2009. A Type II group of variations application (EMEA/H/C/000986/II/0039/G) was submitted on 10 November 2020, with an opinion date of 16 September 2021.

In efficacy studies, the 1-year cumulative probability of testosterone levels below castrate level (≤0.5 ng/mL) was >-10%. The median level of testosterone for degarelix was 0.05 ng/ml, which was the same as the control group. The median change in PSA from baseline for degarelix was -89.2%, compared to -93.0% for the control group. The mean IPSS change for degarelix was -1.71, while the control group showed a mean change of -0.11. The P-value for IPSS mean change was 0.0445. The difference in testosterone suppression rate probabilities between degarelix and goserelin was 3.6%, with a 95% CI lower limit of -1.5%.

Key figures — cited to the source page

1-year cumulative probability of testosterone levels below castrate level (≤0.5 ng/mL)	>-10%	Ferring A S — Firmagon EMA EPAR variation assessment report, p.14
median level of testosterone (degarelix)	0.05	Ferring A S — Firmagon EMA EPAR variation assessment report, p.29
median level of testosterone (control)	0.05	Ferring A S — Firmagon EMA EPAR variation assessment report, p.29
median change in PSA from baseline (degarelix)	-89.2%	Ferring A S — Firmagon EMA EPAR variation assessment report, p.29
median change in PSA from baseline (control)	-93.0	Ferring A S — Firmagon EMA EPAR variation assessment report, p.29
mean IPSS change (degarelix)	-1.71	Ferring A S — Firmagon EMA EPAR variation assessment report, p.29
mean IPSS change (control)	-0.11	Ferring A S — Firmagon EMA EPAR variation assessment report, p.29
MA granted in Europe	February 2009	Ferring A S — Firmagon EMA EPAR variation assessment report, p.8

Source documents

Ferring A S — Firmagon EMA EPAR variation assessment report (EMEA/H/C/000986, 2009) (2009)

Explore the full evidence

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.