FDA Panel Supports Approval of Genentech's Xolair
A Food and Drug Administration advisory panel has voted unanimously to recommend the approval of Xolair, an asthma treatment developed by
Genentech
(DNA)
,
Novartis
(NVS) - Get Report
and
Tanox
(TNOX)
.
The panel voted 11-0, and their recommendation will now go to the full FDA, which will probably
later this year. The FDA normally follows the advice of its advisory panels.
In July 2001, the FDA chose not to approve the drug, asking Genentech and Novartis to provide additional safety data. Some data have suggested the possibility of higher cancer rates in patients treated with Xolair, but no conclusive link has been found. Ultimately, safety concerns didn't prevent the panel from issuing the positive recommendation today.
After the bell, shares of Genentech were down 60 cents from the 4 p.m. EDT close to $39.45.