>The Galvus extension has me dumfounded. The NVS Gallient and Glorius trials provided data for over 8000 patients, supposedly with no skin related issues. Since when does minor side effects during preclinical testing on animals warrant such caution compared to 8000 humans. The Merk Januvia trial appears to have been based on just over 2700 patients (see passage below). It would seem that preclinical animal testing concerns have been way overblown. NVS excercised caution going forward with Galvus and allowed Merk to beat them to the US market. Now it appears that FDA is looking to add to Merks cushion by allow Merk a few more months to launch ahead of Galvus. I don't like to be a conspiracy theorist but this seems suspicious.<
FL: Why would the FDA want to help MRK at the expense of NVS? I really can’t see that.
I think the FDA is just doing its job in the cautious manner to which investors have become accustomed (#msg-13673358). For instance, a few months ago the FDA rejected Cephalon’s Sparlon NDA because of an alleged case of Stevens-Johnson syndrome that CEPH denies even existed (#msg-12568512).
In the case of Galvus, I can’t say the FDA’s concerns are unwarranted because they have all of the data and we don’t. Let’s be patient and see what happens in February. Regards, Dew
[This may be why NVS was down only 2% today despite the Galvus delay. Diovan, a member of the ARB class for hypertension, is NVS’ largest-selling drug by a wide margin and this study is about a new, higher dose.]
CHICAGO, Nov 13 (Reuters) - Novartis AG <NVS> on Monday said its Diovan blood-pressure drug, given at high doses, helped to significantly reduce levels of protein in the urine of diabetics, a precursor to kidney failure.
A study tested the drug in patients with high blood pressure and type 2 diabetes, in which the body stops producing enough insulin to process sugar in the blood.
Novartis said the 391-patient trial is the largest and longest-running study of different doses of angiotensin receptor blockers, a class of medications used to treat hypertension.
It was the first to test the safety of Diovan, known generically as valsartan, in a 640-milligram dose, which is not currently approved.
The study "found that high doses of Diovan provided a greater reduction in microalbuminuria than lower doses," said lead investigator Dr. Norman Hollenberg of Brigham and Women's Hospital in Boston.
Side effects included slightly more dizziness and headache at the higher dose.
The study was presented the annual scientific meeting of the American Heart Association in Chicago. <<
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