FDA panel rejects Boehringer Ingelheim's sexual desire drug
This article was originally published in Scrip
The US FDA's advisory committee for reproductive health drugs unanimously recommended on 18 June that the agency reject Boehringer Ingelheim's NDA to market flibanserin as a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women.
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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."