patient schreef op 1 augustus 2010 09:52:
ZALBIN™: Preliminary Feedback Received from FDA on BLA; MAA Withdrawn in Europe
HGS received preliminary written feedback from the FDA regarding the Company’s Biologics License Application seeking approval to market 900-mcg ZALBIN dosed every two weeks for the treatment of chronic hepatitis C. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely, as previously reported. In April 2010, HGS announced that Novartis withdrew its Marketing Authorization Application for JOULFERON®, as ZALBIN is known outside the United States, from the European Medicines Agency. HGS and Novartis are considering development of ZALBIN dosed every four weeks. ZALBIN is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006
Weer een potentiele concurrent minder voor Locteron. Ben benieuwd of Biolex samen met Octoplus na dit nieuws ook de éénmaal per 4 weken dosering gaat onderzoeken.