HGS said that the FDA has expressed concerns regarding the risk benefit assessment of Zalbin dosed at 900-mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely.
Zalbin is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialisation agreement entered into in 2006.
HGS and Novartis are considering development of Zalbin dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this Zalbin regimen.
The FDA feedback was provided via a Discipline Review letter, which is a standard vehicle for review disciplines (eg, clinical) to convey early thoughts on possible deficiencies of an application. In April 2010, HGS said that Novartis withdrew its marketing authorisation application (MAA) for Joulferon from the European Medicines Agency.