In the crowded diabetes market that includes drugs from Amylin Pharmaceuticals
One of the studies tested Onglyza in combination with the common front-line treatment metformin in subjects that hadn't been on any medication. The drug combination was able to lower glucose levels better than either of the drugs alone.
The other two studies tested patients who were already on medication but weren't able to get their blood glucose levels down far enough. In combination with their current medication -- generic glyburide, Takeda's Actos or GlaxoSmithKline's
The proposed safety changes at the FDA to make stricter requirements for diabetes drugs might come into play for Onglyza's U.S. approval, but the companies will probably be able to scoot by. They have tested the drug at concentrations up to 80 times the proposed dose for short periods of time and at twice the proposed dose for up to two years, which should give the agency reassurance that the drug is fairly safe.
Eventually the companies are going to have to differentiate Onglyza from the other diabetes drugs in head-to-head trials -- in fact, they have one test pitting Onglyza against Merck's
After that, the company can worry about swinging for the fences.
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