IoM report: Randomised trials not the gold standard in postmarketing safety studies
This article was originally published in Scrip
The traditional hierarchies of evidence based on study design used to decide whether a new drug should be allowed on to the market should be turned upside down when it comes to postmarketing safety studies, the US Institute of Medicine (IoM) has advised the US FDA in a report released on 9 July.
You may also be interested in...
Clouds had seemed to hover over ThromboGenics ophthalmologic drug ocriplasmin earlier this week when the USFDA staff expressed worries about the extent of adverse events reported in the two Phase III trials supporting its biologics license application (BLA). But they were substantially dispersed on July 26 when the agency's panel of outside advisors voted unanimously that its benefits outweigh its risks. The solid endorsement came despite the fact that, minutes before the decision, three of the 10 committee members had said that the federal regulator should demand new safety studies before approving the intravitreal injection, intended to treat symptomatic vitreomacular adhesions (sVMA) including macular hole.
The USFDA ophthalmic drugs advisory committee did more than recommend that the agency approve the pending biologics license application (BLA) from Roche's Genentech arm to add to the label for Lucentis (ranibizumab) a new indication for the treatment of diabetic macular oedema (DMO). The outside experts aggressively cheered the drug.
US FDA staff analysts are largely supportive of the application from Roche's Genentech unit to add a new indication to its ophthalmic anti-VEGF antibody Lucentis (ranibizumab). The agency's advisory board of outside experts will on July 26 consider whether the drug should be approved as a treatment for diabetic macular oedema (DMO). The staff analysts from the division of transplant and ophthalmic products note that Lucentis, approved for treatment of wet age-related macular degeneration (AMD) and macular oedema following retinal vein occlusion, has been on the US market since June 2006 and "no postmarketing data or experience as been submitted to the division which affects the safety or efficacy of the product."