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An FDA advisory committee recently convened to decide if new evidence suggested type 2 diabetes drug Avandia should be taken off of the market.

FDA Advisory Committee Meets To Decide If Avandia Will Stay On The Market

In 2007, Dr. Steven Nissen and Kathy Wolski of the Cleveland Clinic published an analysis on the cardiovascular risk associated with Avandia (rosiglitazone) that sparked a controversy that is still burning strong (for our coverage of the issue, see Learning Curve from diaTribe #6). As a reminder, Avandia (made by GlaxoSmithKline) belongs to the thiazolidinedione (TZD) class of drugs for the treatment of type 2 diabetes, and there is currently only one other TZD available in the US and Europe called Actos (made by Takeda). Although Dr. Nissen’s analysis suggested Avandia could increase the risk of heart attacks by 43%, some physicians and statisticians had concerns about the validity of the study and questioned its conclusions. An FDA panel met on July 30, 2007 to deliberate on the controversy, and two weeks later, a black box warning was issued by the FDA for Avandia as well as Actos, emphasizing that TZDs may cause or exacerbate heart failure or bone fracture, especially in certain patient populations. Since that meeting, more studies and analyses have been published, including another by Dr. Nissen (reiterating his earlier conclusions) and the full results of the RECORD trial (a five-year clinical study evaluating the safety of Avandia – see NewNowNext from diaTribe #19).

In April, 2010, the Senate Finance Committee published a scathing report criticizing both GlaxoSmithKline and FDA for the way that safety concerns about the drug were handled between 2007 and 2010. These events paved the way for yet another meeting of the FDA’s advisory committee this summer from July 13-14, this time to decide if the new evidence suggested Avandia should be taken off of the market and the ongoing safety trial for the drug (dubbed TIDE) be halted. We were at the meeting bright and early (the room was eventually standing-room-only), and after two days of deliberation, the committee voted 20 to 12 to keep Avandia on the market and continue the TIDE trial, with the majority of panelists suggesting further warnings or restrictions be added to Avandia’s label (FDA has since weighed in against the panel to say that no new patients should enroll in TIDE until further notice). While there is ongoing concern, most panelists did not feel there was sufficient evidence to warrant removal of the drug from the market and emphasized it may still be an important option for some patients. For now, we must wait for the FDA’s final decision (the advisory committee’s recommendations are technically only suggestions), but we note it is extremely rare for the FDA to go against the committee’s vote. The vote was complicated as there were actually five choices for panelists across a broad spectrum of agreement – such a wide range may enable FDA to more easily decide its own course, as there was no clear majority. We did find it notable that the panel seems to have little confidence in many doctors’ ability to explain risks to patients adequately. We will continue to follow this issue closely. --JS

Vivus’ new weight loss drug Qnexa also faced scrutiny from the FDA Advisory Committee meeting this month – and was voted down 10-6.

The Fate Of Vivus’ Weight Loss Drug Qnexa Rests With FDA

Just one day after the controversial meeting on Avandia, the FDA Advisory Committee met again, this time to consider the approval of a new weight loss drug named Qnexa, made by Vivus. After a short day of deliberation, the committee delivered the decision not to approve the drug, 10 to 6 – we were also at this meeting reporting, and this vote was contrary to our expectations. However, while the majority of panelists voted not to approve Qnexa, the outcome of this decision is much more nuanced than a quick glance at the vote would portray, as most panelists were self-proclaimed to be “on the fence.” Ultimately, the panel was concerned with unanswered questions about the long-term safety of the drug, primarily in the domains of cardiovascular risk, teratogenicity (the risk for birth defects), and psychiatric problems, and particularly given the large population in which the drug would likely be used. Most panelists agreed that they would like to see more data, although there was clear indecision over the question if the data was needed before or after the drug was approved. Overall, it is clear this panel would have been more comfortable with a much more restricted label and the two-year data that Vivus plans to submit to FDA (only one-year data was available to the panel at the time of their meeting, though we note that current FDA guidelines suggest only one year of efficacy and safety data is necessary to approve a weight loss drug). We are eager to see what the FDA’s final decision on the drug will be, as the advisory committee’s vote is only a recommendation, albeit one that the FDA rarely goes against – we would not expect the FDA to go against the panel in this case, given the current highly politicized environment. Please see NewNowNext in diaTribe #21 for more information about Qnexa’s notable effects on weight loss and NewNowNext in diaTribe #18 to learn more about Arena’s lorcaserin and Orexigen’s Contrave, two other weight loss drugs set to undergo review by the FDA before the end of this year. Because patients and providers need alternatives, we hope for approval with restrictions on who can use the drug while more data is amassed. --JS

The JewelPUMP is based on Debiotech’s MEMS micro-pump technology, allowing for a large insulin reservoir while maintaining a small size.

Debiotech Showcases New Insulin “JewelPUMP” at ADA

One of the most interesting exhibits at this year's ADA Scientific Sessions was the booth showcasing the "JewelPUMP,” a new patch pump based on MEMS micro-pump technology, which allows for a large insulin reservoir. The patch pump consists of three parts: a disposable cradle containing a needle that is placed on the skin (with an automated insertion device available), a disposable insulin reservoir (which also contains a battery and the micro-pump), and an electronic control module (available with colorful covers). The overall dimensions are smaller in all directions than the current Insulet OmniPod. The JewelPUMP reservoir can hold up to 450 units of insulin (for up to six days’ use), although the cradle officially needs replacing every three days. The pump technology allows a minimum dose of 0.02 units (compared to 0.05 units on leading competitors), and has sensors that can easily detect occlusion.

Notably, this is also one of the first pumps showcasing software that directly interfaces with a popular cell phone platform – Google’s Android – which may make pumping less intrusive and obvious for daily life with diabetes. Though we have heard some concerns over achieving FDA approval using a consumer interface, the software operates independently from the telephone and automatically locks to prevent an accidental bolus when trying to use other features on the phone. The pump software appears to have all of our favorite features, and the sleek interface made it easy to graphically display and edit basal profiles and review other pump settings. The JewelPUMP is currently under review at FDA, and the company hopes to have the pump on the market in the US next year. However, pump manufacturing has shown the devil is in the details; in particular, it will be important to see how Debiotech builds customer service and manufacturing versus the US pump players today that have made major commitments in these areas, including Medtronic, J&J/Animas, and Insulet. --DL

In the integrated system, continuous glucose readings from the DexCom sensor will be sent wirelessly to the OmniPod PDM.

Application Submitted to FDA for Integrated Insulet OmniPod Insulin Pump and DexCom Continuous Glucose Monitor

We were very excited to hear recently that DexCom has filed an application with FDA for an integrated glucose management system, combining Insulet’s tubeless disposable pump, the OmniPod (see Test Drive from diaTribe #4), with DexCom’s continuous glucose monitor (see our Test Drive from diaTribe #15). Notably, the integrated system will combine the pump controller, CGM handheld, and blood glucose meter all into the OmniPod personal diabetes manager (PDM), eliminating the need for carrying three different devices; continuous glucose readings from the DexCom sensor will be sent wirelessly to the OmniPod PDM. Like the Medtronic Paradigm system, users of the system will still need two separate skin punctures at two sites, one for insulin delivery and the other for the CGM sensor. The OmniPod disposable pump and the DexCom CGM are two products that have both advanced diabetes technology significantly, so the new combination is certainly one we are very interested in trying. It seems that both companies have done a good job of keeping the integration user-friendly, without adding any extra barriers for FDA approval. That said, FDA has new guidelines for insulin pumps, so we are not sure how long we’ll have to wait – we hope for a product launch in the next year. --AB

JDRF will lend its “halo” to sanofi-aventis toward the development of new cure-based type 1 therapies.

JDRF and sanofi-aventis Form Promising Partnership To Develop New Therapies For Type 1 Diabetes

Earlier this month, the Juvenile Diabetes Research Foundation (JDRF) announced a partnership with sanofi-aventis to jointly fund, research, and develop new therapeutics for type 1 diabetes. Funding from the partnership will be specifically directed to research on the immune system and the regeneration of pancreatic beta cells, toward the ultimate prevention or cure for type 1 diabetes. We will be greatly looking forward to the products of this partnership, as both organizations bring outstanding expertise to the table. The JDRF will leverage its network of researchers, institutions, and biotech partners and continue to advance its mission to bring about better treatment options and a cure for people with type 1 diabetes, and sanofi-aventis will add its global resources and substantial experience in drug development to the mix. Both organizations also stand to benefit from the collaboration; JDRF may receive future financial compensation from sanofi-aventis, while the drug maker will retain intellectual property rights for discoveries made by researchers in the program. It’s very encouraging to see a large company like sanofi-aventis exploring new therapies for type 1 diabetes; traditionally, major pharmaceutical companies without device businesses have focused on the larger type 2 diabetes market. Additionally, the JDRF deserves significant credit for continuing to attack type 1 diabetes on all fronts by partnering with industry – stay tuned for updates on this collaboration. --AB

The new OneTouch Delica Lancing System is 40% thinner than the 28 gauge lancets that were previously available from the company.

OneTouch Introduces New Delica Lancing System

Virtually everyone finds diabetes management challenging on some level – for many, test strips and meters can be a hassle, and lancing your finger may still be painful, despite the serious strides made on this front in the last several decades. The new OneTouch Delica Lancing System tries to tackle pain by offering a 33 gauge lancet, which is 40% thinner than the 28 gauge lancets that were previously available from the company. According to the manufacturer, in a clinical study of nearly 200 people with diabetes, four out of five reported the OneTouch Delica Lancing System was “virtually painless” and the most comfortable lancing device they have ever used. In a tiny unofficial study of n=1, diaTribe Editor-in-Chief Kelly Close tried the Delica and definitely thought it was improved over the last LifeScan lancing devices – much better, in fact! Obviously, this is subjective, but diaTribe Summer Intern Adam Brown (also with type 1) tried the Delica at the recent ADA conference and was impressed. According to OneTouch, the key is in reducing the vibration that makes lancing more painful – at least for those in our office, the lancing device does seem to live up to the promises we have had to date. --KC

Jeffrey Brewer

JDRF Announces New President/CEO, Jeffrey Brewer

We were thrilled to hear recently that Jeffrey Brewer was named President and CEO of the JDRF. Mr. Brewer brings substantial personal and professional experience to his new position: the highly regarded entrepreneur was previously co-founder of Overture Services, an early Web 2.0 company purchased by Yahoo! for $1.6 billion in 2003. Mr. Brewer was also Chief Technology Officer at CitySearch and Executive Chairman of the non-profit organization Kickstart International. And as the father of a child with type 1 diabetes, there’s no doubt that Mr. Brewer will bring considerable passion to the job as well. Mr. Brewer has also been an active JDRF volunteer, heavily involved in the Artificial Pancreas Project (by many views, he launched it) and serving as a director of JDRF’s International Board since 2004. We salute Brewer for taking on this role, which has had a number of CEOs in recent years. We feel great as patients that Brewer has taken on the role, and we look forward to his continued great influence on JDRF in the months and years ahead. --AB

Johnson & Johnson recently announced an agreement with Diamyd Medical to support the research and development of Diamyd’s GAD 65 vaccine for the treatment of type 1 diabetes.

Johnson & Johnson Announces Partnership with Diamyd Medical for Type 1 Diabetes Immune Therapy Vaccine

Johnson & Johnson (owner of LifeScan, Animas, the J&J Diabetes Institute, and Children with Diabetes) recently announced an agreement with Diamyd Medical to support the research and development of Diamyd’s GAD 65 vaccine for the treatment (but ideally the prevention) of type 1 diabetes. The vaccine (appropriately dubbed the Diamyd vaccine) works by exposing the body to GAD antigen, one of the common self-targets of autoimmune attack in type 1 diabetes. The therapy is currently in phase 3 pre-approval trials in both Europe and the United States and is intended for patients recently diagnosed with type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA). Promisingly, though only tested in a small number of subjects thus far, the vaccine has been demonstrated to slow the destruction of insulin-producing beta cells in the pancreas with limited side effects. We see this agreement as a positive step for patients and the further development of this unique therapy – support from a large company such as Johnson & Johnson is surely promising for Diamyd and will help differentiate the vaccine from the number of other cure-based therapies in development. If someone you know is between 10 and 20 years old and was diagnosed with type 1 diabetes within the past three months, be sure to check out DiaPrevent, a national diabetes research study evaluating the potential of the Diamyd vaccine to help preserve insulin producing capacity in new patients. --AB