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Long term use of Egrifta

Mar 25, 2012

Hi Nelson, Do you know if EMD Serono is doing any long term studies on the use of Egrifta? Was this not a requirement when the drug was approved by the FDA? Should they not have started a study by now? thanks. W.C.

Response from Mr. Vergel

Yes, they are required by the FDA to do a 5 year placebo control study in people with diabetes to see if it increases incidence of Retinopathy and a 10 year observational open label controlled study with HIV+ patients with lipohypertrophy to see if the drug increases cancer rates.

I will post the study enrollment links soon.


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