TNX-901 is a drug being tested at National Jewish Medical and Research Center and other locations across the United States. It is believed that the drug may prevent allergic reactions to small amounts of peanuts, such as those remnant in foods.
The U.S. Food and Drug Administration (FDA) has "fast-tracked" the drug. A drug is given fast-track status if it meets a medical need not currently being met by any medication. TNX-901 is made by a Houston-based company called Tanox; there is a legal dispute against this laboratory that the drug is based on the same anti-asthma sciences paid for by Genentech and Novartis. Trials of the drug were mired in legal battles.
TNX-901 is an anti-IgE antibody. IgE antibody is the receptor responsible for allergic reactions and severe asthma attacks. An anti-IgE antibody binds IgE and prevents it from initiating an allergic reaction. In clinical trials, people who were very allergic to peanuts when they consumed an average of half a peanut were able to consume up to 9 peanuts before they started to have symptoms . Therefore the drug wouldn't cure allergies, but it would prevent reactions from accidental exposure. Note that this study was not done on people allergic enough to die from peanut traces.
A similar drug is already on the market for asthma, under the name Xolair (Omalizumab is the generic name, but it's not generic yet). The problem is that Xolair isn't approved for use in food allergies and TNX-901 can't be released because Xolair's manufacturer sued Tanox for patent infringement. One could obtain a prescription for Xolair without it being approved for use in allergies, but most health insurance will not cover it without FDA approval, meaning it could cost on the order of $1000 a month for a patient.
Recently, TNX-901 has been shelved by its creator Tanox in exchange for money from Genentech and Novartis, and the three companies plan to focus on researching Xolair for use against peanut allergies instead of TNX-901. Xolair entered Phase II trials for use against peanut allergies in July 2004.
- Leung, D.Y.; Sampson, H.A.; Yunginger, J.W.; Burks, A.W. Jr; Schneider, L.C.; Wortel, C.H.; Davis, F.M.; Hyun, J.D.; Shanahan, W.R. Jr (2003-03-13), "Effect of anti-IgE therapy in patients with peanut allergy", N Engl J Med, 348 (11): 986–993 Check date values in: