Novartis SA reports the U.S. FDA has demanded additional data, including a clinical study in patients with kidney impairment, before giving Galvus its approval. Why the holdup?

The FDA wants more data studying Galvus in patients with impaired kidneys. It had been thought that Galvus might have an advantage because it is not processed by the kidneys, while Januvia is. But another molecule created when the body metabolizes Galvus does build up in the kidney.

In the Feb. 1 issue of The New England Journal of Medicine, David M. Nathan, a Harvard Medical School endocrinologist, noted that it was surprising that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan is a consultant for Novartis and other drug makers but not Merck.

There are several potential concerns about DPP-4 drugs, clear evidence has not turned up in clinical trials so far. The medicines could affect the immune system, because a receptor on immune cells is very similar to DPP-4. Merck says that Januvia was designed to bind only to the DPP-4 enzyme, reducing the chances of these side effects. Patients with impaired kidneys have more of the drug in their bloodstream and would be more likely to experience side effects.

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!

In the $20 billion diabetes market, when drugs make their way onto the scene, it's a head-turning event. So far, one drug is gaining ground and two of them are raising interest.

Januvia, manufactured by Merck, was recently approved for the treatment of diabetes. Januvia is used with diet and exercise to lower blood sugar in patients with type 2 diabetes. Januvia lowers blood sugar when blood sugar is high, especially after a meal. It also lowers blood sugar between meals and helps to improve the levels of insulin produced by your own body after a meal. The drug is unlikely to cause your blood sugar to be lowered to a dangerous level because it does not work when your blood sugar is low. Januvia faces potential competition from an experimental drug, Galvus. The drugs are similar in many respects, including their status as once-a-day pills, and their ability to lower blood-sugar levels in diabetics while helping them to lose weight, or at least to avoid gaining it. The FDA delayed its decision on Galvus, so we may be waiting till the first half of 2007 to see it in action.

Acomplia, manufactured by Sanofi-Aventis, is in hot pursuit of FDA approval. Acomplia is primarily a treatment for diabetics, but the drug is unusually multi-faceted. It was created to help people quit smoking and lose fat by blocking circuitry in the brain that gives the body cravings. The drug works by blocking the same circuitry in the brain that gives pot-smokers the munchies. The drug is expected to receive FDA approval in the first half of 2007.

This just in: Novartis, the multi-billion dollar drug conglomerate based on Basel Switzerland, released a statement saying that their newest drug for type 2 diabetes, Galvus, does not cause skin lesions on monkeys. Thanks for the earth-shattering info. Lord knows that we were all wondering how those monkeys were doing, so we're thrilled to hear that they're skin is silky smooth.

The other part of Navrtis' public whine session resulted from what they feel is the unnecessary delay in the FDA's review process of Galvus. The drug itself, which does not have to be injected and does not have side effects like weight gain and water retention, is part of a new wave of drugs that are designed to use the body's own physiological mechanisms to control blood sugar. Based on that information, sure, get the drug out as soon as it is deemed. I think we can all agree on that. But, to say that just because monkeys didn't get lesions that the drug is ready to be ingested into the human body doesn't exactly constitute a safe product, now does it? Oh wait, now this just came in: Novartis has research on 1,000 patients who used Galvus for as long as two years alone or in combination with other drugs -- none of which exhibited skin problems in people with type 2. Okay, now we're at least getting somewhere. Monkeys don't get lesions, and now we know that humans don't, either. Hold on a second, I'm going to crack open the champagne. Drinking it may be problem, however, since my tongue is planted far too firmly in my cheek at the moment.

Galvus may turn out to be a wonderful drug for people with type 2, but until enough research is done on its overall safety, let's be happy that the FDA is doing their job on this one. Remember Phen-Phen? Or Valtrex? Or any other drug that somehow snuck by the safety standards of the FDA, only to later be linked to a myriad of health problems. The fact is that these drug companies are only concerned with one drug: the almighty dollar. It's already estimated that Galvus could generate at least $1 billion a year in sales. By the way, that was billion with a B. B for big bucks. B for beautiful yachts and a bevy of Benzes. And B for "Better get that drug on the market pronto!!" The pharmaceuticals business is a strange one, selling drugs that can potentially help people live longer, healthier lives for amounts of money that most people will never make in their lives. It's all about the bottom line, which is why this press release was issued by Novartis -- and not because they are overly concerned with helping people with diabetes. It sucks, but it's true. But, if there's any good that we know will come out of all of this, it's that we can sleep easier at night because we now know that their test monkeys and humans are lesion-free. Thanks, Novartis. You're the best.

On Tuesday, October 17, the clouds parted and the medicinal gatekeepers welcomed the birth of a little bundle of joy from Merck & Co, named Januvia. Weighing in at $4.86 per tablet, and guaranteed to control blood sugars without the undesirable side effect of weight gain, Merck said Januvia would be in pharmacies in the near future.

This is a new class of pills called DPP-4, or dipeptidyl peptidase IV. These are inhibitors that work to enhance the body's own ability to lower blood sugar. In clinical trials, patients did not gain weight. Yippee! Taken once a day, Januvia is expected to face competition from Novartis AG's rival medicine Galvus, which is awaiting FDA approval, possibly next month. The first generation of drugs designed to combat insulin resistance notoriously caused water retention and gain weight.

The empirical evidence is shining through already. A survey of about 60 physicians, conducted by Reuters Primary Research, shows the vast majority of doctors intend to start prescribing Januvia and Galvus right away. Dr. Stuart Weiss, a New York University Medical Center endocrinologist, said the drug's ability to control blood sugar spikes without added weight gain was a big draw. "In the face of a diabetes epidemic, this drug ... is particularly an inviting choice," said Weiss, who has consulted for several Merck competitors, including Novartis. If the near $5 a day price tag doesn't send your budget into a tailspin, you might have the shelf space for a DPP-4 in your near future. Praise be the DPP, for the sugars will come down and the scales won't creep up!

My previous blog was about the meeting now underway in Copenhagen of the European Association for the Study of Diabetes (EASD). More significant news from that meeting: Galvus, the diabetes drug manufactured by Novartis, appears to work as well as GlaxoSmithKline's Avandia - but without the nasty side effects.

Galvus and Avandia are both designed to lower blood sugar levels. However, in the case of Galvus, this is achieved without causing weight gain and with less incidence of fluid retention, which is seen with Avandia. This is all good news for patients, said Emanuele Bosi of Milan's San Raffaele University, while addressing the EASD meeting. Remarked Bosi, neither patients nor their physicians should accept side effects of diabetes meds as a normal part of treatment. Great - who could disagree with that?

Naturally, this represents a major coup for Novartis in the unrelenting battle for dominance of the diabetes drug market. On the other hand, Novartis is not home free: Januvia, which works in the same way as Galvus and is manufactured by Merck & Co., should also reach markets soon enough too.

Don't call your doctor just yet though. Galvus is not yet approved for sale in the United States.

There's a report in The New York Times today about the growing market for diabetes drugs--and how that market grows as the so-called diabetes epidemic escalates. The article also touches on the positive spin-off in terms of money-making possibilities for the drug companies and their investors. (The market for diabetes drugs is now worth an estimated $15 billion, and that is expected to grow to at least $25 billion worldwide by 2001!)

The article is worth a look because it profiles the four diabetes-fighting drugs that are generating the most excitement these days. They are: 1. Byetta, 2. Exubera, 3. Galvus, and 4. Januvia. Byetta (pictured) is already available and comes in the form of an injection. Exubera is an inhalable insulin delivery device that will be released for sale in the US in July. Galvus and Januvia come in the form of pills and are expected to arrive on the market next year.

The reason there is so much excitement surrounding these drugs is that they are relatively hassle- and pain-free to use and, best of all, they help treat the underlying causes of diabetes. Anyway, this article gives a handy overview of what all the fuss is about - check it out!

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.

In a new report from CNN, it's being predicted that drug companies Merck and Novartis are about to "lock horns." That is, they're both developing two similar diabetes drugs, both of which have the potential to have a groundbreaking impact on the market. In addition, both these drugs are now under review by the US Food and Drug Administration. The result? Analysts are saying these giant companies could be drawn into a fight for dominance of the diabetes drug market.

Merck is the second biggest drug manufacturer in the US, and is developing the drug Januvia. The Swiss company Novartis has been making great inroads into the US market in recent years, and hopes to introduce a similar drug called Galvus. Both drugs are designed to lower blood sugar in Type 2 diabetics. Says market analyst Jon LeCroy, "You really have two products battling it out. The question is: who's the winner and who's taking second share?"

The US Food and Drug Administration is going to review the oral drug Galvus in preparation for its entry to the US market. Galvus is manufactured by the Swiss company Novartis and has been developed to treat Type 2 diabetes. The brand is one of a new type of drugs that work by improving the body's ability to lower blood sugar in Type 2 diabetics. Competition is fierce among drug companies to get their own versions of the medication out, and fast. In addition to Galvus, Merck & Co., Inc., have submitted an application for review of their equivalent: Januvia. Glaxo Smith Kline and Bristol-Meyers Squibb Co. are also working on similar drugs.