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Posts with tag Takeda

Take Avandia off the market, says FDA official

Details are emerging from today's advisory committee meeting on Glaxo's Avandia. First up was a presentation by Dr. Robert Ratner of Washington's MedStar Research Institute outlining the unprecedented spread of type 2 diabetes. Ratner emphasized the inadequacy of current drug therapies for diabetes and the strain on the health system caused by the disease. The possible implication: Avandia does more good than harm right now, so let's keep it as an option.

Next, in written preview comments, an official from the US Food and Drug Administration stated his belief that the diabetes drug should be taken off the market. The official, Dr. David Graham, says the heart risks posed by Avandia mean it's just not worth the risk to patients. Especially, he said, not when there are safer alternatives like Actos (by Takeda), which also stabilizes blood sugar levels.

It's a significant step that someone from the FDA publicly made this statement. But will anything come of it? Maybe not. The decision about whether or not Avandia stays on the market is not up to Dr. Graham, who The New York Times reports has a history of coming down harder on drug risks than many colleagues. (Give the guy a medal!) Thing is: there appear to be plenty of other officials within the FDA who don't agree with Graham's interpretation.

Damning FDA report confirms Avandia risks

The beleaguered US Food and Drug Administration (FDA) today released its review of the Avandia debacle. It contains a fairly damning assessment of what went wrong, one that implicates not only Avandia's manufacturer GlaxoSmithKline, but also the FDA itself.

The 436-page review confirms that Avandia does indeed increase the risk of heart problems, a claim that Glaxo has vigorously denied. (Can't wait to see how they respond to this.) The FDA reviewers concluded that the risk is also far greater than that posed by a similar drug, Actos, which is manufactured by Takeda. In addition, the FDA reviewers were dismissive of the studies conducted by Glaxo - studies that the drugmaker claimed provided proof of Avandia's safety. The report also restates the allegation that Glaxo tried to coerce a doctor into remaining silent about the risks posed to diabetics from taking Avandia.

The report goes on to find fault with the FDA's inaction and, by implication, its completely pathetic pandering to Glaxo. Now, even insiders are publicly saying FDA officials repeatedly put the interests of Glaxo above the interests, health and safety of consumers.

All-in-all, this represents a big victory for Glaxo/BigPharma's critics. It almost goes without saying that this report likely marks the end of the line for Avandia. Perhaps more significant could be the impact of the whole mess on the FDA. The review effectively highlights the shortcomings of the agency for all to see, greatly strengthening the hand of its critics - both in and outside government - who are calling for major reforms there.

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Stay tuned for news of the advisory committee hearing on Avandia, which is scheduled to be held Monday.

Daily Pill Restores Natural Blood Sugar Balance

The FDA has approved sitagliptin phosphate tablets to improve blood glucose levels in patients with type 2 diabetes. The drug, named Januvia, is proudly presented to the diabetic community by Merck and Co.

JANUVIA, a once-daily pill, enhances your body's natural ability to balance blood sugar levels. Your body sends important messages to your pancreas to try to balance high blood sugar. In response, your pancreas makes more insulin and signals the liver to make less sugar. But a substance in your body called DPP-4 blocks some of these important messages. JANUVIA works by blocking DPP-4, so more of the important messages get through. It also helps your pancreas make more insulin and signal your liver to make less sugar. Another feature of this new drug is the ability to prevent your sugar from going too low. JANUVIA works only when your blood sugar levels are high, or out of balance. When your blood sugar levels are at a healthy balance, JANUVIA doesn't have an effect. Because JANUVIA stops working before your blood sugar gets too low, it is not likely to lower your blood sugar to a potentially dangerous level (hypoglycemia). One more bonus to JANUVIA is the fact that this drug did not show weight gain in most patients during clinical trials.

Could this be the answer for your diabetes dilemma? Next time you swing by your doctor's office, mention that new drug Merck released. I'm sure your doctor will be as thrilled to see your numbers controlled as you'll be to see your natural ability to control them restored. Best of luck to those who find their diabetic solution in JANUVIA!

Galvus-Actos combo delays need for insulin, says drug giant Novartis

Drug manufacturer Novartis claims that combining its new drug Galvus with another drug called Actos is so effective it will postpone diabetic patients' need for insulin. Galvus (vildagliptin) is designed to reduce high blood sugar levels and comes in the form of a pill, taken once a day. Novartis says that taking Galvus along with a dose of Takeda's Actos reduces blood sugar levels by an average of 1.9 percent. The company also says the combo is even more effective for people with very high blood sugar levels.

Galvus is one of the new so-called blockbuster diabetes drugs that are expected to earn big bucks for their manufacturers. Novartis will pit Galvus against Merck's Januvia, which works in a similar way to Galvus. Galvus has received a lot of media hype because Novartis says it not only stabilizes blood sugar levels, but that it does so in a way that does not cause weight gain, a common and dreaded side-effect of some diabetes meds.

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