July News and Trends

| July 15, 2012

First Prescription Weight Loss Treatment Approved by FDA in 13 Years
SAN DIEGO, California and WOODCLIFF LAKE, New Jersey (PRNewswire)—Arena Pharmaceuticals, Inc. and Eisai Inc. announced that the United States Food and Drug Administration (FDA) has approved lorcaserin hydrochloride. The drug will be available under the brand name Belviq (pronounced BEL-VEEK) and will serve as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30kg/m2 or greater (obese), or 27kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). The indication includes the following limitations of use: The safety and efficacy of coadministration of Belviq with other products intended for weight loss and the effect of Belviq on cardiovascular morbidity and mortality have not been established.

“The FDA approval of Belviq is an important development for patients who struggle with obesity or are overweight with comorbidities and need help with chronic weight management beyond diet and exercise,” said Jack Lief, Arena’s President and Chief Executive Officer. “We thank our entire team and the patients who participated in our clinical trial program for making this achievement possible.”

Three double-blind, randomized, placebo-controlled trials demonstrated that Belviq along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years.

“Diet, exercise, and behavioral therapy alone may not result in sustained weight loss for many overweight and obese people trying to lose weight,” said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. “Belviq represents an important therapeutic option for physicians responsible for the medical management of their patients who are overweight or obese.”

In clinical trials, the most common adverse reactions for patients without diabetes treated with Belviq were headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.

The FDA has recommended that Belviq be classified by the United States Drug Enforcement Administration (DEA) as a scheduled drug. The DEA will review the FDA’s recommendation and determine the final scheduling designation. Once the DEA has provided the final scheduling designation, Eisai will announce when Belviq will be available to patients and physicians in the United States.

Arena will manufacture and supply the finished commercial product from its facility in Switzerland, and Eisai will market and distribute BELVIQ in the United States.

As part of the approval of Belviq, the companies committed to conduct post-marketing studies to assess the safety and efficacy of Belviq for weight management in obese pediatric patients, as well as to evaluate the effect of long-term treatment with Belviq on the incidence of major adverse cardiovascular events in subjects with overweight and obesity with cardiovascular disease or multiple cardiovascular risk factors. The cardiovascular outcomes trial will include echocardiographic assessments.

To read the full press release, please visit http://invest.arenapharm.com/releasedetail.cfm?ReleaseID=687182

The Centers for Medicare and Medicaid Services release decision on coverage for the laparoscopic sleeve gastrectomy—American Society for Metabolic and Bariatric Surgery Responds
Centers for Medicare and Medicaid (CMS) Decision:
Medicare Administrative Contractors acting within their respective jurisdictions may determine coverage of stand-alone laparoscopic sleeve gastrectomy (LSG) for the treatment of co-morbid conditions related to obesity in Medicare beneficiaries only when all of the following conditions A-C are satisfied.
1. The beneficiary has a body-mass index (BMI) ≥ 35kg/m2;
2. The beneficiary has at least one co-morbidity related to obesity, and;
3. The beneficiary has been previously unsuccessful with medical treatment for obesity.

CMS Conclusions and Rationale for Decision. The available evidence does not clearly and broadly distinguish the patients who will experience an improved outcome from those who will derive harm such as postoperative complications or adverse effects from LSG. However, taking into consideration the seriousness of obesity, the possibility of benefit in highly selected patients in qualified centers, we believe that local Medicare contractor determination on a case-by-case basis balances these considerations in the interests of our beneficiaries. Our local contractors are in a better position to consider characteristics of individual beneficiaries and the performance of eligible bariatric centers within their jurisdictions. Therefore, Medicare Administrative Contractors acting within their respective jurisdictions will make an initial determination of coverage under section 1862(a)(1)(A) and we are not making a national coverage determination under section 1869(F).

ASMBS Response:
Access to Care Alert—The CMS Final Decision
from http://asmbs.org/2012/06/
access-to-care-alert-the-cms-final-decision/

Dear Colleagues,
On June 27, 2012, The Centers for Medicare and Medicaid Services (CMS) released their decision on coverage for the laparoscopic sleeve gastrectomy (LSG). The final decision will allow laparoscopic sleeve gastrectomy to be covered by intermediary Medicare administrators as a stand-alone procedure at their discretion.

On behalf of our patients, ASMBS is very pleased and gratified that CMS has recognized the true value and compelling need for coverage of this procedure. ASMBS will immediately initiate the formal pathway for coverage with each regional CMS intermediary by reiterating the arguments for coverage as expressed in our excellent April 2012 appeal letter written by John Morton, MD (Access to Care Committee Chair and Secretary/Treasurer) and Matt Brengman, MD (Insurance Committee Chair) ASMBS Response to CMS Sleeve Coverage Decision.

In addition, in the Top 5 on the 5th July 2012 newsletter from ASMBS, the Access Committee will provide additional instructions as to how you and your patients can help in the effort to achieve coverage in each particular region of the country. This again demonstrates our future need to work together in regional collaboration.

While more work needs to be done, this experience demonstrates that the ASMBS Rapid Response Initiative for Access to Care works.

The overwhelming response from patients, surgeons and integrated health members, along with the strong evidence base for LSG, provided CMS with a persuasive argument for LSG coverage. In addition, the multi-disciplinary support of the American College of Surgeons, SAGES, The Obesity Society and the American Society of Bariatric Physicians displayed an Obesity Care Coalition in action working for our patients’ best welfare. We are thankful to the Obesity Action Coalition and our industry partners, Covidien and Ethicon, who all played vital roles. We will now go forth to each individual intermediary, and this decision will open the door to widespread coverage based on the strong, available evidence. We are confident coverage will be achieved.

Sincerely,

Jaime Ponce, MD
President, ASMBS

Robin Blackstone, MD
Immediate Past President, ASMBS
Ninh Nguyen, MD

President-Elect, ASMBS

John Morton, MD
Secretary-Treasurer and Chair, Access to Care Committee ASMBS

Matthew Brengman, MD
Chair, Insurance Committee ASMBS

Deep brain stimulation surgery may be effective treatment for obesity
Washington, DC—Researchers have found that deep brain stimulation reduces binge eating in mice, suggesting that this surgery, which is approved for treatment of certain neurologic and psychiatric disorders, may also be an effective therapy for obesity.

Currently the United States Food and Drug Administration (FDA) has approved deep brain stimulation for use in various conditions that affect the brain, including Parkinson’s disease and essential tremor.

The procedure does not destroy any part of the brain and typically does not cause pain, said the study’s presenting author, Casey Halpern, MD, a fifth-year neurosurgery resident physician at the University of Pennsylvania, Philadelphia.

“Doing brain surgery for obesity treatment is a controversial idea,” according to Halpern.

“However, binge eating is a common feature of obese patients that frequently is associated with suboptimal treatment outcomes,” Halpern noted.
To read the full article, visit http://www.andhranews.net/Health/2012/Deep-brain-stimulation-surgery-effective-treatment-1021.htm

Obesity vaccine takes a step forward
(Los Angeles Times)—Behind the shimmering prospect of a newly approved prescription weight-loss medication and the possibility of two more to come is a more distant glimmer of hope for those who have already cracked the obesity barrier: a vaccine that could reset the body’s metabolism and prompt weight loss even with a modest change in calories taken in or burned up in exercise. New research on mice demonstrates it could happen.

The study tried two different formulations of a vaccine designed to reduce production of the hormone somatostatin in mice that had become obese after they were routinely fed high-fat chow. The formulations differed not in their bioengineered active ingredient but in the “adjuvant” that was added to stoke the body’s response to the vaccine. Both formulations showed a marked effect: Compared with obese mice who did not get the vaccine, the weight gain of those who got either formulation slowed—even though all the mice continued to get the same high-fat diet.

By the end of the study, the weight gain of vaccine-treated mice was a much smaller proportion of overall body weight than it was for those that got a sham infusion. And compared with the control group, the mice that got either vaccine formulation had notably higher levels of a hormone called “growth factor” (better known to humans as human growth factor, or HGH) and more modest increases in insulin-like growth factor 1 or IGF-1.

The study was published in the Journal of Animal Science and Biotechnology, an open-access publication of BioMedCentral.
To read the full article from the Los Angeles Times, visit http://www.latimes.com/health/boostershots/la-heb-obesity-vaccine-20120709,0,4907293.story.
To read the study abstract from the Journal of Animal Science and Biotechnology, visit http://www.jasbsci.com/
content/3/1/21/abstract

Category: News and Trends

Comments are closed.