Beefing up the case for a rival weight loss drug

As FDA advisers meet today to discuss whether to approve Vivus’s weight loss drug Qnexa, new research shows that a competing medicine not only helps people shed pounds but does so with few side effects.

A study out today in the New England Journal of Medicine finds that after one year’s treatment with Arena Pharmaceutical’s lorcaserin, nearly half the patients on the diet drug lost at least 5% of their body weight — corresponding to an average loss of around 6 kilograms — compared to only around 20% of subjects taking placebo pills. What’s more, the drug did not increase blood pressure or cause any other heart problems among the more than 1,000 patients monitored for two years, the company-sponsored trial revealed.

“In this long-term study of lorcaserin for treating patients for obesity, there was good weight loss, outstanding safety profile and the drug was extremely well-tolerated,” lead author Steven Smith of the Translational Research Institute for Metabolism and Diabetes in Winter Park, Florida, told Bloomberg.

So, watch out Qnexa — here comes lorcaserin. Arena’s diet pill is slated to have its day in the FDA spotlight in September.

In a busy week for the FDA, expert panel set to consider diet drug

The focus in the media this week may be on the US Food and Drug Administration’s deliberations around what to do with the diabetes blockbuster Avandia. Yet the agency’s advisory committee on endocrinologic and metabolic drugs has another drug to consider as well.

On Thursday, the panel will turn its attention at Qnexa, the weight-loss drug developed by Mountain View, California-based Vivus. The drug is yet to be approved, but in two phase 3 clinical trials subjects on the medicine — a combination of the appetite suppressant phentermine and the anticonvulsant topirimate — lost a placebo-corrected average of 9% of their body weight. A phase 2 trial also demonstrated Qnexa’s efficacy against sleep apnea.

But the drug has also been linked to anxiety, depression and concentration lapses, among other ailments, according to briefing documents released today. The report also questioned the lack of data in pregnant women and on long-term cardiovascular safety.

If Qnexa gets the advisory committee’s blessing, it could mean big business for Vivus and a head start over the company’s competitors, California-based Arena Pharmaceuticals and Orexigen Therapeutics, which both have new obesity drugs in development. Arena’s Lorcaserin and Orexigen’s Contrave will face similar scrutiny by the same panel later this year. The London-based market research agency Datamonitor estimates that the global diet-pill market could exceed $10 billion by 2018, Bloomberg reports.

For more on these new antiobesity drugs, check out our news story from earlier this year.

Genetic linkage between risk for obesity and Alzheimer’s

elderlyman.jpgSwedish scientists have found that a variation of the FTO gene linked to an increased risk of obesity may also be associated with an increased risk of Alzheimer’s disease and dementia. Their study also found carrying both the risky FTO allele with another gene known to be associated with Alzheimer’s disease increases the risk of dementia by 50%. The findings were announced earlier today at the Alzheimer’s Association International Conference on Alzheimer’s Disease in Honolulu, Hawaii.

Over nine years, researchers followed 1,003 elderly subjects who initially presented no signs of dementia. The found that those people carried two copies of the A variant of the FTO gene had a 58% increased risk for Alzheimer’s disease and a 48% increased risk for developing dementia. The FTO A allele, which occurs at a frequency of about 45% in Central and Western Europeans and 52% in West Africans, has been previously shown to correlate with increased BMI and increased risk for obesity in both children and adults. The Swedish researchers found that those individuals who carried two copies of FTO A as well as the e4 allele of the gene APOE saw their risk factor for dementia double. It’s estimated that about 25% of people carry at least one copy of the APOE e4 allele.

Image by pedrosimoes7 via Flickr Creative Commons

Artificial pancreas offers diabetes hope

Cross posted from Nature’s The Great Beyond blog.

diabetespatient1.jpgAn artificial pancreas that can help control the havoc-wreaking diabetes causing hormones has been developed and successfully tested.

The system was developed at Boston University (BU), and consists of a blood glucose monitor and insulin pump hooked up to a laptop that runs a programme to control the levels of the important hormones insulin and glucagon. Administering insulin to a type 1 diabetes patient always carries a risk of hypoglycaemia with it. But by running an algorithm that monitors blood sugar levels and is capable of administering both blood-sugar raising and lowering hormones – glucagon and insulin respectively – this system seems to remove that risk.

Read the rest of the post on The Great Beyond.

One step closer to an artificial pancreas

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An artificial pancreas currently in development could ultimately help diabetes patients keep blood sugar levels normal, without lifting – or pricking – a finger. Though the device’s exact setup hasn’t been determined, plans include implanted glucose-monitoring sensors that would transmit information to an insulin pump, with dosing determined by algorithm.

The Juvenile Diabetes Research Foundation (JDRF) announced today a partnership with Animas Corporation to further the the artificial pancreas’ development. With JDRF contributing $8 million in support to a big-time company like Animas, the team expects to apply for regulatory approval within the next four years.

“A lot of people want relief – they don’t want to have to worry if they’ll go blind or if they’ll develop heart problems because of poor blood sugar management,” Aaron Kowalski, assistant vice president for Glucose Control Research at JDRF, said at the press conference. “This is one of the biggest leaps forward we’ve had for this cause in years.”

The first generation of the artificial pancreas will still require routine blood sugar monitoring and insulin dosing by users, Kowalski says, but the system will kick in should glucose levels go to a dangerous extreme. Down the line, a fully automated, closed-loop system is the goal, which could eliminate the need for outside monitoring, as well as give a break to those who don’t like the sight of a pricked finger.

Image: Istock Photo