FDA Drug Withdrawals due to Lack of Efficacy: LUVERIS, ADVICOR, SIMCOR
FDA BRIEF: Week of April 11, 2016
- FDA approved LUVERIS in 2004, under the Accelerated Approval regulations
- Indication: Stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound luteinizing hormone deficiency
- EMD Serono requested wiithdrawal of NDA approval as it was not feasible to complete a trial that the company had agreed to at the time of approval
- FDA approved ADVICOR in 2001 and SIMCOR in 2008
- Indication: Treatment of hypercholesterolemia
- Collective evidence from several large cardiovascular outcome trials no longer support efficacy conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDLcholesterol levels results in reduction in the risk of cardiovascular events
- Benefits of ADVICOR and SIMCOR no longer outweigh the risks