We had previously noted the approval of degarelix in Europe on December 23rd.
It has been kindly pointed out to us that late on Christmas Eve the US Food and Drug Administration also approved the second generation LHRH antagonist degarelix for clinical use and marketing. We apologize to readers for missing this approval (with the poor excuse that your primary correspondent has spent much of the past week in bed with a bug and your secondary correspondent was in Israel).
Neither the FDA nor Ferring Pharmaceuticals have managed to get a media release up on their own web sites, but a copy of a media release issued by Ferring can be found on PR Newswire.
The indication for the use of degarelix in the USA is apparently broad, like that in Europe: “for advanced prostate cancer.” This gives the prostate cancer community the ability to use this drug within its approved label for almost any man with prostate cancer that has progressed outside the prostate.
We have noted previously that, in clinical trial reports, degarelix has been associated with “significant” injection site reactions in some 40 percent of patients. In their media release, Ferring notes that, “Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in 2% or less of patients receiving degarelix.”
Apparently the brand name that will be used for Degarelix in the USA is still under discussion between Ferring Pharmaceuticals, the FDA, and others. We have pointed out elsewhere that the approved brand name in Europe will be Firmagon®.
Our thanks to Kathy Meade for bringing this approval to our notice.
Filed under: Drugs in development Tagged: | Degarelix
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