Xolair won't get 2001 approval

Genentech (DNA) and partner Novartis (NVS; SWX:NOVN) received a complete response letter from the FDA asking for additional preclinical and clinical data analysis and pharmacokinetic information to support their BLA for Xolair omalizumab to treat adult allergic asthma. As a result, the companies said there will not be an FDA approval of the anti-IgE antibody in 2001. Moreover, they said conservative estimates of resubmission range from 2002 to early 2003. The companies plan to meet with the FDA within the next month, which DNA told BioCentury "would give a better idea on the timeline."

In particular, DNA said that the agency "is looking for more patient experience on the drug." NVS told BioCentury that the FDA is concerned with "primarily theoretical risks of uncommon events and whether the safety data is robust enough to rule out such theoretical risks." One potential uncommon event could be the incidence of thrombocytopenia, which was seen in cynomolgus monkeys in studies of the partners' second generation higher affinity anti-IgE antibody (rhuMAb-E26). These results led the FDA to place Xolair on clinical hold, which was ultimately removed in September 2000, allowing the companies to continue their studies. At that time, DNA said sustained reductions in platelet count or bleeding abnormalities were not seen in the 1,950 patients treated with Xolair in Phase III studies. ...