|Boston Scientific Receives FDA Approval; Vivus Drug Could Become the First New Anti-Obesity Medication|
|By Staff and Wire Reports|
|Wednesday, 22 February 2012 19:47|
Boston Scientific Corporation's (NYSE:BSX) ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System and TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System have received U.S. Food and Drug Administration (FDA) approval for use in patients experiencing an acute myocardial infarction (AMI), or heart attack. They are the only drug-eluting stent (DES) systems in the U.S. with an approved indication to treat patients with AMI.
The new indication, which accounts for approximately 10 percent of all coronary interventions, is a result of FDA review of data from the Paclitaxel (TAXUS) clinical program and HORIZONS-AMI trial. In the global HORIZONS-AMI trial, 3,006 patients were randomized to receive either drug-eluting stents or bare-metal stents for the treatment of AMI, making it the largest randomized trial to study coronary stents in heart attack patients.
"The AMI indication is a testament to our long-term commitment to innovation and leading clinical science in support of advanced DES technologies," said Keith D. Dawkins, M.D., Global Chief Medical Officer for Boston Scientific. "Clinical data from the HORIZONS-AMI trial showed that, in patients with AMI, paclitaxel-eluting stents were superior in efficacy to bare-metal stents, significantly reducing clinical and angiographic restenosis compared to bare-metal stents, while demonstrating a comparable safety profile at three years. We are proud that our investments in randomized trials such as HORIZONS-AMI have led to the approval of products to treat a broader range of patients with coronary artery disease."
"The new indication for heart attack patients should give U.S. physicians the confidence to treat this high-risk group with Boston Scientific's advanced paclitaxel-eluting stent technology backed by a robust clinical program that spans 10 years of research," said Hank Kucheman, Chief Executive Officer of Boston Scientific. "The AMI indication reinforces the safety and effectiveness of the ION and TAXUS Liberte paclitaxel-eluting stents in treating challenging patients and lesions in both clinical and real-world practice. The inclusion of the ION Stent for this indication should be welcome news for physicians and patients. This innovative platinum chromium stent has been very well received since its U.S. launch last year based on its exceptional visibility, radial strength and deliverability."
The Company's ION Stent System incorporates a unique platinum chromium (PtCr) alloy designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.
A previously rejected weight loss pill won an overwhelming endorsement from public health advisers Wednesday, raising hopes that the drug from Vivus Inc. (NASDAQ:VVUS) 10.55 0.00(0.00%) Feb 21|After Hours: 20.99 Up 10.44 (98.96%), could become the first new anti-obesity medication to reach the U.S. market in more than a decade.
The Food and Drug Administration has rejected three weight loss pills in the last two years, including Vivus' pill Qnexa, due to safety concerns. Experts agree new weight loss drugs are needed to treat an estimated 75 million obese adults in the U.S., but the string of rejections has raised questions of whether any pharmaceutical treatment is safe enough to win approval.
At a public meeting Wednesday, an FDA panel of outside physicians voted 20-2 in favor of the weight loss drug from Vivus, setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.
Nearly all the panelists backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.
"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.
The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected by mid-April.
In a key question, the physicians said Vivus could conduct the cardiovascular safety study after FDA approval. A requirement to conduct the study ahead of market approval would cost the company millions of dollars and take at least three more years.
"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."
Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.
The FDA rejected Qnexa in October 2010, citing numerous side effects including elevated heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.
Vivus President Peter Tam said the overwhelming panel vote Wednesday indicates doctors recognize the urgent need for effective weight loss drugs.
"Right now there aren't any good treatments out there besides dieting and bariatric surgery — clearly there's a huge gap," Tam said.
With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.
Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anti-seizure and anti-migraine drug sold by Johnson & Johnson (NYSE:JNJ) as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.
If approved, FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa. The drug would only be available from 10 mail-order pharmacies.
Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.
Fen-phen is just one example in the decadeslong history of failed weight loss drugs, which have continued to pile up in recent years.
Four years ago Sanofi-Aventis SA (NYSE:SNY) discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories (NYSE:ABT) withdrew its drug Meridia after a study showed it increased heart attack and stroke. The drug won approval in 1997 in the wake of the recall of fenfluramine but never achieved widespread use due to modest weight loss and safety concerns. Only 100,000 prescriptions were written in the U.S. during Meridia's last full-year on the market.
Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is sold over the counter as alli by GlaxoSmithKline (NYSE:GSK). The drug is not widely used because of modest weight loss results and unpleasant side effects, including gas and diarrhea.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Ron Cohen, M.D., President & CEO will present at the 2012 RBC Capital Markets' Global Healthcare Conference on Tuesday, February 28, 2012 at 11 a.m. ET at the New York Palace, New York City, NY.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will webcast its presentation at the Citi 2012 Global Health Care Conference in New York City.
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), announced today that former Stryker biomaterials product development specialist, Brian Hess, has joined InVivo as its Director of Product Development.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR"), a leading provider of Personal Health Records ("PHR"), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that the Company has received another patent.
mPhase Technologies, Inc. (OTCBB: XDSL) said today that it has filed a provisional patent application for a novel drug delivery system based on its Smart Surface technology.
Oxygen Biotherapeutics, Inc. (NASDAQ:OXBT) today announced that the Company plans to report third quarter fiscal year 2012 financial results on Form 10-Q on Thursday, March 15, 2012.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided an update on recent progress with its clinical programs and reported financial results for the quarter and year ended December 31, 2011.