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Several months after an FDA advisory committee delivered an overwhelmingly positive vote (20-2) in favor of approving Vivus’ Qnexa for the treatment of obesity (see our new now next in diaTribe #40), the agency has done it yet again, voting 18-4 (with one abstention) earlier this month to approve Arena’s Lorqess for the treatment of obesity. While the votes for the two drugs are similar at first glance, Lorqess had less enthusiasm, given its more modest efficacy (an average of 3-4% total body weight loss after one year of treatment –this is “average” and some patients experienced more weight loss and some less). Nonetheless, the day’s deliberations reaffirmed that obesity is finally coming closer to being recognized on par with other diseases, worthy and in great need of additional treatment options.
During the FDA’s first review of Lorqess in 2010, the agency decided not to approve the drug largely due to its potential cancer risk. Specifically, breast tissue (mammary) tumors and brain tumors (astrocytomas) were observed at higher rates in mice and rats treated with the drug (see our new now next in diaTribe #26). Since then, results from additional studies and analyses Arena performed have made the FDA more confident in the drug’s safety (judging by the FDA briefing document), as its cancer risk was found to be lower than initially believed. This additional level of comfort with the drug’s safety, combined with the recognition of the unmet need for the treatment of obesity, appeared heavily influence the positive vote by the advisory committee. We also believe the committee recognizes that while “average” weight loss wasn’t that high, Lorqess will prompt higher-than-average weight loss for some patients (and lower than average for others), and availability of the therapy may be particularly positive for them. Also, having several alternatives would be a positive for healthcare providers, many of whom have, to date, been frustrated by the lack of current options.
Although the committee and the FDA noted some questions still remain regarding the drug’s safety (e.g., whether Lorqess’ cancer risk in animals is relevant to humans, and whether cardiovascular risk could definitively be ruled out), they seemed to be comfortable to wait to characterize the remaining uncertainties after Lorqess is on the market and these questions can be properly assessed (it is very difficult to do large enough trials before a drug is approved to assess cancer risk in particular). While approval is by no means guaranteed, Lorqess’ prospects of approval are now much more encouraging, following the positive vote. The FDA now has until June 27 to consider the panel’s recommendation and to make a decision on whether to approve Lorqess. Exciting times ahead – 13 years without any new drugs to treat obesity, and now two could potentially be approved by mid-summer! –VW
In April, the FDA denied approval of the DPP-4 inhibitor alogliptin in the US. Takeda (the drug’s manufacturer) has not yet revealed the reasons behind the FDA’s decision, although the company believes it can address the agency’s concerns with already available data and results from ongoing studies. Takeda has indicated that it plans to reapply for approval shortly, with an expectation that the drug could be approved by early 2013. As a reminder, alogliptin has been available in Japan since 2010 under the brand name Nesina. DPP-4 inhibitors are type 2 diabetes therapies that help the body secrete insulin only when blood glucose levels are high – so there is no hypoglycemia associated with the drugs, and there is also no weight gain, unlike with a number of current diabetes therapies. There are three currently approved DPP-4 inhibitors in the US, including Januvia (sitagliptin), Onglyza (saxagliptin), and Tradjenta (linagliptin).
Based on the studies we’ve seen, alogliptin appears to be quite similar to the already approved DPP-4 inhibitors in many respects. But what could distinguish alogliptin is that it may also become available in combination, in a single pill, with the type 2 diabetes therapy Actos (pioglitazone). Actos is a TZD (thiazolidinedione) and works to improve blood glucose control by increasing the body’s sensitivity to insulin. Therefore, by targeting both insulin secretion (with a DPP-4 inhibitor) and insulin resistance (with a TZD), a combination alogliptin/Actos pill could form a very useful therapy for many people with type 2 diabetes. We note that some studies have associated use of Actos for more than one year with bladder cancer. In response, the FDA recently updated the medication’s label and will be looking for further clarity as more extensive trial data becomes available. For more information, please see new now next in diaTribe #34. Over the coming months, we’ll be keeping our ears to the ground for any more information surrounding alogliptin’s rejection and Takeda’s plans to resubmit the drug for approval in the US. Meanwhile, alogliptin is under review for approval in Europe, and a decision is expected in 2013. –BK
Earlier in May, we were encouraged to hear that Dexcom has filed its new Gen 4 CGM sensor with the FDA. The review process typically takes six months or longer, meaning Dexcom might even see FDA approval of the new sensor before the end of 2012. As a reminder, the original Gen 4 sensor was approved in Europe in March 2011 (see new now next in diaTribe #31), though we understand that the US version has several incremental improvements over the currently available Gen 4 sensor in Europe (sold as part of the Animas Vibe integrated pump/CGM). Here in the US, Dexcom has been encouraged by early interactions with the FDA thus far, and we certainly hope this continues as the Gen 4 makes its way through the regulatory process. We’ll be excited to give it a test drive once it becomes available (see diaTribe #15 for our test drive of the Dexcom Seven Plus). For those across the Atlantic, Dexcom is planning to launch the new updated Gen 4 CGM in Europe later this summer.
The new Gen 4 sensor is expected to be over 20% more accurate and 25% better in hypoglycemia detection relative to the current Seven Plus. The Gen 4 transmitter will also have a much longer communication range with the receiver – up to 30 feet normally and up to 50 feet (!) if it’s in line of sight, compared to a range of five feet cited in the label for the Seven Plus. Dexcom’s new sensor will feature a new receiver design as well, including a color screen, slimmer profile, and a different navigation interface. Down the road, the Gen 4 will also be integrated into the Animas Vibe and Insulet OmniPod insulin pumps, though Dexcom has not yet disclosed a timeline on when these might be filed with the FDA. –AB
On May 14, HBO premiered its four-part documentary series on obesity, The Weight of the Nation. Each part – entitled “Consequences,” “Choices,” “Children in Crisis,” and “Challenges” – addressed head-on a different aspect of the obesity epidemic, featuring a powerful mix of personal stories, compelling statistics, and opinions from an array of leading experts. In a rare and extremely commendable move, HBO has also posted all four hour-long films in their entirety online at http://theweightofthenation.hbo.com/films (go to the “Watch” tab to view all four films), plus videos explaining the overall project and a dozen bonus short films on such topics as “Poverty and Obesity,” “The Biology of Weight Loss,” and “Obesity and Type 2 Diabetes.” We highly recommend watching this – we have seen it and were blown away by it. The site also has an impressive assortment of learning materials and a whole section on advocacy ideas, a clear (and refreshing) demonstration to us that the project has loftier goals than just making an of-the-moment movie. The documentary has an impressive list of co-presenters: the Institute of Medicine, NIH, CDC, the Michael & Susan Dell Foundation, and Kaiser Permanente. Executive producers Sheila Nevins and John Hoffman have won an Emmy Award for their previous public health documentary The Alzheimer’s Project, and we expect this will be up for many awards as well.
We were moved, educated, angered, and inspired after seeing the film’s fourth segment in a pre-screening at the CDC’s recent Weight of the Nation Conference. We think HBO has done a most impressive job with this project, which executive producer John Hoffman hopes will be the largest public health campaign on obesity that America has ever seen. We hope so too. Notably, HBO is also sending out 40,000 DVD Screening Kits (complete with discussion guides) to community organizations around the US. Given this commitment and the high regard for the film’s co-presenters, we believe The Weight of the Nation may well bring more widespread public attention to obesity – one comparison has been the way in which Rachel Carson’s Silent Spring called environmentalists to action in the 1960s (she is credited with launching the environmental movement, and her work is said to have enabled a major pesticide ban in the early 1970s). –AW/AB/KC
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