Diabetes

Nissen questions approval process for diabetes drugs

Christe Bruderlin-Nelson — Wed, 02 Jul 2008 10:38:51 -0400

Steven Nissen (photo) of the Cleveland Clinic made a statement to the FDA that might hurt diabetes drug manufacturers--especially Bristol-Myers Squibb and AstraZeneca, which are currently in the FDA approval process with diabetes drugs.

A top expert in the field of cardiology, Nissen urged FDA to take a more stringent approach to new drug reviews when it comes to diabetes, and to take extra steps to ensure the drugs also lower cardiovascular risk and ultimately influence lifespan. He said there are so many drugs for diabetes available today that FDA can afford to be more selective. Nissen made his comments on day one of a two-day meeting scheduled to end this afternoon.

Nissen said that drugs that focus only on lowering blood glucose are too simplistic and that diabetes medications must ultimately reduce the risk of cardiovascular disease, as cardiovascular disease is responsible for about 75 percent of deaths in diabetic individuals. However, such a move would change the drug approval process entirely, moving approval based on surrogate endpoints toward later outcomes--and could affect drugs aimed at treating almost every disease state known.

Companies like GlaxoSmithKline and Takeda Pharmaceutical--major players in the $6 billion dollar diabetes market--are also likely to be displeased with the statements, as slower drug approval processes would likely increase manufacturing and approval costs and decrease profits. However, thus far there are no drugs on the market with a proven cardiovascular benefit for over 90 percent of diabetics, those with Type 2 diabetes. Recent controversy about Avandia, charged with increasing risk of heart attack, likely played a role in the planning of the meeting.

Nissen said, "If we take drugs forward that lower blood sugar but increase the risk of death and heart attack, we haven't done diabetics any favors."

- get the full story from the Wall Street Journal
- read more at CNN Money

ADA news has potential to reshape market

Tracy Staton — Tue, 10 Jun 2008 11:36:11 -0400

Another week, another big medical society meeting sending shock-waves--good and bad--through the pharma biz. This week, of course, it's the wrap-up of the American Diabetes Association confab. With diabetes a growing problem both in the U.S. and abroad, the market for treatments is exploding--and so any news on new approaches and alternatives is bound to shake things up. It'll take awhile for the dust to settle, but in the meantime, we'll flag a few developments to watch:

Takeda's Actos could be effective at preventing diabetes. In a study of patients with pre-diabetic symptoms, the drug cut conversion to active diabetes by 81 percent, researchers said.
Sanofi-Aventis said that Acomplia, its weight-loss med, controlled blood sugar in patients with type 2 diabetes three times better than insulin did; the company plans to apply for a diabetes indication worldwide next year.
A third big study--after the ACCORD and ADVANCE news reported yesterday--may help cut through the clutter on new ways to proceed with treatment, the Wall Street Journal Health Blog reported. To avoid the heart complications of diabetes, patients should cut cholesterol, control blood pressure, and avoid major blood-sugar drops--more than one of the latter doubled the risk of death over the seven-and-a-half year study. Plus, aggressive blood sugar control early in the disease may work wonders, but later on could be useless or even counterproductive.
Merck's Januvia and Byetta, the Amylin and Eli Lilly med, have some competition breathing down their necks. You'll recall that Novo Nordisk released data on its once-daily liraglutide med suggesting that it outperformed the twice-daily Byetta. Januvia faces possible rivals from Bristol-Myers Squibb and Takeda Pharmaceuticals, which both released data showing their candidates at least match the Merck drug.
Lilly and Amylin, however, struck back with news about their once-weekly version of Byetta, which posted favorable data during the meeting--showing that the less frequent dosing might even be more effective than the daily version.
Merck, for its part, sought to cement Januvia's market position with a study showing the drug combined with metformin positively affected beta cell function, the so-called "holy grail" of diabetes treatment.

Those are the ADA highlights. Now we'll be watching to see how it all shakes out in the marketplace.

- see the Forbes story
- check out Hemscott's coverage
- read the News Wise piece on Actos
- find the Acomplia news in Forbes
- get the Health Blog item

Novo drug bests Byetta in ADA study

Tracy Staton — Mon, 09 Jun 2008 11:03:14 -0400

Amylin Pharmaceuticals' stock is suffering from a Novo Nordisk study that showed its experimental diabetes drug liraglutide outperformed Amylin's flagship drug Byetta, co-developed with Eli Lilly; shares dropped more than 8 percent Friday to close at $29.93. Report

New drug-spending leader: Diabetes

Thu, 15 May 2008 06:59:58 -0400

New data on pharma sales details some big shifts in spending. Diabetes meds have displaced cholesterol drugs as the leading drivers of spending growth, for one thing; generic competition is reining in cholesterol costs even as usage of the meds is increasing. Meanwhile, there's been growth in overall diabetes-drug use, and a shift toward pricier treatments, boosting 2007 spending by 12 percent. Overall drug spending grew by only 2 percent last year as patients used more generics.

Plus, safety concerns affected spending on antidepressants, hormone replacement therapy, and anemia drugs, Medco Health Solutions reports. Safety warnings on Procrit, Epogen, and Aranesp depressed sales by 15 percent, while hormone replacement therapy usage dropped by 9.2 percent. Suicide-risk warnings (and generic competition) hampered growth in the antidepressant market.

A separate report from IMS Health showed that the global market for cancer meds is advancing by leaps and bounds, twice as fast as the growth in all other pharmaceuticals. As emerging countries spend more on healthcare, they're investing more in cancer treatments; they're expected to power up spending on these meds by 12 to 15 percent a year through 2012. The overall global drug market, by contrast, is expected to grow by 6.4 percent.

- find the news at the Wall Street Journal Health Blog
- see the Pharmalot item
- check out the story from the Associated Press
- read the article at CNN Money

Novartis restricts Zelnorm to emergencies

Thu, 03 Apr 2008 07:59:55 -0400

Goodbye cruel world. Novartis is pulling the irritable bowel med Zelnorm off the market almost completely, saying it will supply the drug only for emergency use. And even in emergencies, Zelnorm will only be available to patients who don't smoke, and don't have high blood pressure or diabetes or eight other preexisting conditions. And docs who want it must ask the FDA for authorization.

Talk about going out with a whimper. Zelnorm racked up $560 million in sales in 2006, then was withdrawn in March 2007 after it was shown to boost the risk of heart attck, strokes, and chest pain. Novartis eventually made a deal with the FDA to supply Zelnorm to a limited number of patients because it was the only remedy approved for irritable bowel treatment. Eight months later, bye-bye. FDA says the withdrawal was voluntary; we'll have to wait and see whether Novartis offers an explanation.

- see the FDA's press release
- read the Pharmalot item

Related Articles:
Novartis CEO's pay drops with profits. Report
Novartis shares slide after Zelnorm gets yanked. Report
EMEA committee rejects Novartis' Zelnorm. Report

Caraco to withdraw misshaped metformin

Tue, 25 Mar 2008 07:59:54 -0400

A couple of weeks ago, the Los Angeles Times ran a big package about generic meds. Are they really as good as the brand-name versions? Well, the FDA can answer that question about one generic in particular today. The agency asked Caraco Pharmaceutical Laboratories, the U.S. subsidiary of Indian generics giant Sun Pharmaceuticals, to withdraw its diabetes med metformin hydrochloride, "citing efficacy and quality issues," the Business Standard reports.

Caraco will have to withdraw seven lots of the metformin because some tablets were too small and others too big, so like Goldilocks, patients might not have received the correct dose.

- read the Business Standard article
- check out the generics coverage at the LA Times

Related Articles:
Study: Costlier drug worked better. Report
Insurers pay docs for generic-switching. Report
Generics beat down drug price inflation. Report
Op-Ed: Generics aren't always equal. Report
Detroit wins bid for big Caraco expansion. Report

Judge: FDA can't police drugs alone

Mon, 24 Mar 2008 07:59:55 -0400

As Eli Lilly went up to bat in the big Zyprexa trial in Alaska, the judge said lawsuits play a vital role in drug safety. Without them, claims of safety problems "might well go unaddressed," Judge Mark Rindner told the court. Evidence the State of Alaska presented over the past two weeks, he said, shows that the FDA "isn't capable of policing this matter."

Why the commentary? After the state rested its case, Lilly asked the judge for an immediate verdict in its favor (a routine step at this stage of a trial). The FDA should be dealing with these matters, not states, the lawyer said. Rindner, of course, begged to differ.

So the case proceeded. Lilly trotted out a couple of experts: One not only questioned the link between Zyprexa and diabetes, but the link between weight gain and diabetes. Another said doctors should have known about the weight gain problems anyway, and that Zyprexa's side effects are far outweighed by its benefits. The drugmaker will continue to tell its side of the Zyprexa story this week. Stay tuned.

- read the story at the Anchorage Daily News
- check out the item at Pharmalot

Related Articles:
Did Lilly chief support off-label promos? Report
Former FDAer: Lilly hid risks for profit. Report
Lilly gears up for Alaska's Zyprexa trial. Report
Lilly strengthens Zyprexa warnings. Report

Supremes vote 4-4 in pre-emption suit

Tue, 04 Mar 2008 06:59:54 -0500

The Supreme Court came and saw and voted but left no clarity on pre-emption behind. Because Chief Justice John Roberts sat out the case, the vote ended in a 4-4 tie, automatically affirming the lower court's ruling and allowing a liability suit against Pfizer to go forward. In that suit, 27 diabetes patients allege that they suffered liver damage while taking Rezulin, a Warner-Lambert drug withdrawn three years after its 1997 approval at the FDA's request. Pfizer inherited the dispute when it bought Warner-Lambert.

Apparently, Roberts owns between $15,000 and $50,000 in Pfizer stock, so he had to recuse himself. But as a result of his doing so, the Court has left a critical issue open--whether a drugmaker's lying to regulators opens them up to liability despite legal reasoning that FDA approval, being federal, shields companies from state lawsuits. In Michigan, it's illegal to sue a drugmaker over an FDA-approved product unless the company withheld or misrepresented data during the approval process. A definitive ruling would have addressed that provision of the law. Of course, we won't get real closure on pre-emption for months, until the court hears a broader drug-related case.

- read the coverage in The New York Times
- check out the Associated Press story

Related Articles:
Supremes leaning toward pre-emption? Report
Bush: FDA's word shields against lawsuits. Report
Supremes to mull block on drug suits. Report

SPOTLIGHT: Drug scandals cause second-guessing

Tue, 19 Feb 2008 06:59:52 -0500

Recent drug news--from Zyprexa's weight gain-and-diabetes problem to Avandia's heart attack warning to the recent hoopla over Vytorin--have some people asking whether drug therapy is all it's cracked up to be. Report

SPOTLIGHT: Sciele readies six meds for market

Thu, 10 Jan 2008 06:59:52 -0500

Sciele Pharma expects to launch six new products in 2008, executives announced, including a new formulation of its blood pressure drug Sular and two forms of the Prandin drug for Type II diabetes, plus at least two meds awaiting FDA approval. Release