What are going to be the big headlines for 2012? Kelly's reflections.

January and February are months of momentum. The holidays are over. The hard work resumes. Last year’s trends continue. Hopes for new ones are high. This is true every year. But it’s very true now.

Am I talking fast? Well I’ve got a lot to say. In this, the first diaTribe of the new year, I’d like to share the reasons that 2012 could begin a most exciting era in diabetes care – and the reasons are many.

Let’s start with Bydureon, the first once-weekly therapy for type 2 diabetes, which just gained FDA approval a few days ago (finally!). Bydureon has the same active ingredient as Byetta, and it is also similar to Novo Nordisk’s Victoza (all fall into the category of injectable drugs called GLP-1 receptor agonists). However, Bydureon has the least nausea of the three, and its less-frequent injections (once-weekly vs. twice-daily for Byetta and once-daily for Victoza) will hopefully make it easier for patients to fit therapy into the rest of their lives. The new drug does have some downsides, including a multi-step injection procedure similar to the one used for glucagon pens, but overall we are highly optimistic about Bydureon’s US arrival. Several other once-weekly GLP-1 receptor agonists are in the works (Amylin is also developing a once-monthly!), as are some once-weekly oral drugs (e.g., a version of the DPP-4 inhibitor Januvia); with luck, Bydureon and these upcoming drugs will help reduce the daily burden of diabetes management.

2012 looks to be a big year for medical devices, as well. 2011 saw the FDA clear two “smart” blood glucose meters – Telcare’s cellular-enabled meter and J&J LifeScan’s Verio IQ, as well as AgaMatrix/Sanofi’s iPhone-integrated iBGStar meter. Last year also brought FDA clearance for Tandem’s long-awaited, user-interface-focused t:slim pump and for Asante's longer-lasting cartridge-based Pearl pump as well as a European green light for Cellnovo’s pump/meter/online diabetes management system. Already in the new year Medtronic has launched the first remote monitor for CGM/pump systems, the mySentry. We hope that the rest of 2012 will bring, among other good news: US approval and launch of two more-accurate CGM sensors (the Medtronic Enlite and Dexcom G4), as well as Insulet’s smaller OmniPod. Further down the road, all of these advances in accuracy, form factor, and connectivity will be key for the development of the artificial pancreas – an effort that has received strong support from as high up as the US Senate. Based on the FDA’s December 2011 draft guidance for AP systems, we are cautiously optimistic that the final document will appropriately balance the need for innovation with safety, and flexibility with specificity. It still has a way to go, but again, we’re hopeful.

What about insulin? Insulin degludec, Novo Nordisk’s long-acting analog basal analog designed for more flexible dosing and less hypoglycemia than Lantus, is currently under FDA review and will hopefully launch later this year. Cure-based therapies for type 1 diabetes? 2011 was undeniably a disappointing year (see why at in diaTribe.us/cure), but it also made everyone smarter about what avenues to focus on in 2012 and beyond. Complications therapies? In 2012 we expect to see FDA approve Roche’s powerful diabetic macular edema drug Lucentis and to continue hearing all sorts of buzz around Reata/Abbott’s bardoxolone methyl – a potentially disease-modifying molecule for diabetic nephropathy that is currently enrolling for a phase 3 clinical trial.

Finally, how about obesity – arguably the most widespread public health problem in the world? This year the FDA will reevaluate two of the weight-loss drugs that it kept off the market in 2010. Qnexa (phentermine/topiramate), the most effective anti-obesity drug reviewed in recent years, is due for an official decision in April and we should know a lot more at February’s FDA panel meeting; Lorqess (lorcaserin), less potent but possibly valuable in combination therapy, will be reviewed in June. This spring the FDA will also hold a meeting to set the tone for future research – specifically, whether weight-loss drugs should have to be studied in long-term cardiovascular trials prior to approval (as a reminder, these cardiovascular “outcomes” studies have been required for diabetes drugs since 2008). While the FDA should certainly consider the long-term risks of new drugs, the agency is also responsible for driving innovation (i.e., setting regulatory requirements that don’t discourage companies and investors from developing new therapies). The meeting is sure to be controversial, and we’d love to hear what you think about the future of obesity care in America (email us at [email protected]).

At the same time, diabetes and obesity care are facing plenty of challenges in the US and worldwide. The still-slow economy puts limits on what patients can afford, governments around the world are cutting their own healthcare spending, and the FDA faces election-year pressure that could make drug and device approvals especially hard to predict (the very first regulatory news of the year was negative – the FDA’s denial of the SGLT-2 inhibitor dapagliflozin).

I remain confident that therapies will improve and research will advance, even though the progress and availability always fall short of an ideal world. 2012 won’t be an easy year for people with diabetes (as if any year is). But I do believe it will be a momentous one.

Yours,

Kelly L. Close