FDA to review diabetes drug Galvus

Thu, 30 Mar 2006
The Swiss pharmaceutical manufacturing company Novartis has released a statement saying that the Food and Drug Administration in the US has accepted their new type 2 diabetes oral therapy, called Galvus, for standard review. Novartis remain confident that Galvus will be approved for release in Europe during 2006.

Galvus is one of the new breed of oral treatments for type 2 diabetics, that work to enhance bodily ability to lower blood sugar by itself. These drugs traditionally generate large amounts of revenue when approved by the FDA, in some cases this has run into billions of dollars.

Merck &Co Inc, a competitor of Novartis, has also had an application for review accepted by the FDA, and Bristol-Myers Squibb Co. are known to be working on similar treatments. The sector is regarded as being extremely competitive. The companies, according to one expert, appear to now be neck and neck in the race to deliver oral insulin to Europe. Galvus is expected to generate an annual turnover within five years of over $1 billion.

Shares in Novartis leapt up, and the case for approving the drug is said to be strong, with clinical trials data from 4,300 patients.
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