Xolair amendment to be filed next year

Genentech and partner Novartis have announced plans to submit anamendment to their Biologics License Application for the asthma treatment Xolair (omalizumab) to the US Food and Drug Administration in the fourth quarter of 2002.

The announcement clarifies submission expectations originally outlined by the companies in July, after the FDA asked for additional data on the new drug (Marketletter July 19). The amendment will contain data from ongoing studies, and should, say the companies, satisfy the agency's requests for more information. There have been concerns that the FDA would require an additional study, which would have led to even more delays in the program.