Just in time for the New Year, some good news on obesity therapies and insulin delivery devices.

As we wrap up the holiday season, it’s fitting to begin our letter with a bit of good cheer. While we’ve written in some detail about the increasing regulatory hurdles at the FDA, the past several weeks have brought good news on obesity therapies and insulin delivery devices. Is this a change of direction at the FDA or just a coincidence? We don’t know, but it’s still worthy of a New Year’s toast.

On December 7, an advisory committee voted to recommend that the FDA approve Orexigen/Takeda’s weight-loss medication Contrave – the first time since 1997 that the panel has given a thumbs-up to any obesity drug. (The FDA typically follows the advisory committee’s recommendation.) The diaTribe team watched the proceedings in Silver Spring, Maryland, and I even had the chance to speak on behalf of diaTribe and its readers during the panel’s open public hearing. In my four-minute address, I tried to convey just how important the day’s decision would be for obese individuals and for companies working to develop new treatments (please click here to see my comments).

I don’t believe that Contrave (or any other weight-loss drug) is perfect, and I know that it will not end the obesity epidemic. Among other things, tolerability is an issue with Contrave, as it has been with other obesity drugs. But Contrave has already made a huge difference for some people. In clinical trials, those given Contrave lost more weight than those on placebo (nearly 5% of their body weight, on average, which was statistically significant), and some people benefited much more: one of my fellow speakers at the public hearing said she had lost a full 70 pounds! Look at it this way: even if the average weight loss for a drug isn’t high, there might be a small percentage of the population that can benefit – and a “small percentage” could still be many people, since 33% of US adults (that’s over 80 million people) are now obese.

Allergan’s LAP-BAND – which reduces the amount of food your stomach can hold at one time – also received some good news from the FDA recently. Following its own recent advisory committee meeting, the implantable device may soon be available for people with lower body mass index (BMI). Hopefully the FDA will follow its panels’ advice on Contrave and the LAP-BAND, and chances also seem good for the approval of Vivus’ weight-loss drug Qnexa (see New Now Next in diaTribe #26). If all goes well, these anti-obesity therapies could help more people meet their New Year’s resolutions in 2011.

Of course, getting reimbursement for these products – like virtually all products in diabetes – is extremely important, but if the data demonstrate efficacy, we have to assume that insurers and the federal government will recognize the imperative of reducing the country’s obesity rates. A range of obesity companies (including Allergan, Orexigen, and Vivus) also have data showing how diabetes rates drop when the products are used; this is the most compelling data yet in our view for why the drugs and devices should be paid for.

2011 will be an important year for many other devices as well. Two new insulin delivery products were already approved in 2010, Calibra’s Finesse in March and Valeritas’ V-Go (see this issue’s New Now Next) just a few weeks ago. Next year the FDA is also expected to review the next generation of Insulet’s patch pump OmniPod (one third smaller by size and 25% smaller by weight) as well as all-new offerings from Asante (durable pump that uses pre-filled cartridges), D. Medical (patch pump with a spring-based delivery system), Debiotech (microelectromechanical-systems-based semi-disposable pump), and Tandem (durable pump with touch screen display). In addition, two integrated pump/CGM systems (the Insulet/DexCom and the Animas/DexCom) will be up for approval in the US in 2011. Meanwhile, several other products are slated to debut in Europe next year, including CeQur’s disposable “insulin infuser,” J&J/Animas’ integrated pump/continuous glucose monitor system, and Roche/Medingo’s semi-disposable “MicroPump.” Historically, more competition has driven faster innovation, and we’ll be on the lookout...

Further down the road, we hope to see FDA submission of early versions of the artificial pancreas (AP) – a “closed-loop” system that would enable automatic insulin delivery based on continuous glucose monitoring data. In this month’s Conference Pearls, we discuss some of the latest AP progress.

It’s a lot to look forward to. But for now, we’ll take it a year at a time: from all of us at diaTribe, here’s to an exciting 2011.

Glad tidings,

Kelly L. Close