Next-Generation Xolair (omalizumab) sounds pretty good

Implications: This drug seems much more effective at reducing free-IgE levels than is Xolair.  Overall, Xolair has given many patients a tremendous improvement in their quality of life, but it hasn't fulfilled many of its promises. Frankly, some of Xolair's benefits are disappointing, particularly in the 40 or 50% of patients who use it without achieving great results.  In particular, Xolair patients who are on Advair 500/50 can sometimes get down to Advair 250/50, but it's been difficult tapering them to lower doses of inhaled corticosteroids.

Analysis: One of the problems with Xolair is that it an antibody to all IgE.  Future generations of monoclonal antibodies directed against IgE will be designed to act only against dust mite IgE.  Or cat IgE.

Or, if we're really lucky one day, against PEANUT IgE.  The study that was published on Xolair and peanuts showed that those allergic to peanuts increased their tolerance from 1/2 of one peanut to 9 peanuts.

Though a discernable difference, it is not exactly what we were hoping for.  Another company, Tanox, was working on another anti-IgE specifically to fight peanut allergy.  According to a Texas Monthly article from the mid-1990's, Genentech (DNA) stole Tanox's anti-IgE ideas, then ending up buying Tanox after wearing them down in court.  And then Genentech shut down the research involving Tanox's unique approach to anti-IgE, and made no further plans to investigate peanut allergy with Xolair.

OK, back to this improved anti-IgE.  If an asthma biotech drug is going to cost a couple thousand dollars a month, it's reasonable for us to expect it to work pretty well; either significantly improving quality of life, reducing visits to the E.R., and reducing the need for potentially harmful high-dose inhaled corticosteroids.

 The classic Xolair study showed that you could decrease an asthmatic's use of inhaled steroids.  But guess what?  The steroid they had patients using in that study was beclomethasone.  That's right, they didn't use fluticasone or budesonide or any of the high-potency inhaled steroids.  They used the equivalent of a Model T.  Instead of a modern Mercedes-Benz or BMW, they used an old Ford Model T.  They had to do that because they wanted the results to be clinically significant, with a p-value <.05.

So, in summary, we all know that Xolair is the first of many biotech drugs to come out of the gate to treat severe asthma.  While it has been helpful in many patients, the market is ready for new, improved versions of anti-IgE.  Especially one that needs to be used exactly one time, and one time only---Xolair must be used once or twice per month, indefinitely.