MJ schreef:
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ec.europa.eu/health/documents/communi...Vooral het laatste stukje is het meest belangrijk..trek u conclusies!!
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LEZEN IS INDERDAAD EEN KUNST, WAT STAAT HIERONDER:
Dr. Bruno Giannetti, Chief Operations Officer of Pharming, said: “We are very pleased with the EMA feed back on our dossier and therefore we continue to remain confident that our new MAA dossier has addressed all issues from the previous CHMP opinion in 2008. We believe that our current clinical database strongly supports the efficacy and safety of Rhucin for single and repeated use in the treatment of all types of acute angioedema attacks. We are confident that we will be able to satisfactorily address all outstanding CHMP questions in the coming months.”
Efficacy of Rhucin has been demonstrated in two randomized controlled studies and is supported by four open label studies, including the successful treatment of potentially life-threatening laryngeal attacks. In the RCT studies patients received Rhucin (100 U/kg or 50 U/kg body weight) or saline (placebo) control treatment. Patients receiving Rhucin responded rapidly to treatment, with statistically significant and clinically relevant shorter time to onset of relief and time to minimal symptoms compared to placebo. Following treatment with Rhucin, no relapse of attacks was recorded. Superiority over placebo was also consistently supported by exploratory endpoints, sensitivity analyses and subgroup statistical analyses.
The updated safety dataset, submitted to the European Medicines Agency in September, comprises a total of 405 administrations in 139 subjects. Fourteen patients received at least five repeat administrations of Rhucin and one patient received 20 administrations. Rhucin was well tolerated with the adverse event profile observed in the controlled studies was similar to that of placebo. There were no significant infusion site reactions such as pain. Immunogenicity testing revealed a reassuring immuno-safety profile, without evidence for induction of neutralizing antibodies against Rhucin or for the induction of allergic responses.
WAAROP WAS RHUCIN DE VORIGE KEER AFGEKEURD EN WAT LEES JE HIERBOVEN... KORTOM WAAROP AFGEKEURD IS IS NU HARD AANGEWERKT EN WORDT HIERBOVEN AL UITGESPROKEN, BV:
ur current clinical database strongly supports the efficacy and safety of Rhucin for single and repeated use in the treatment of all types of acute angioedema attacks.
TREK DUS JE CONCLUSIES...