June 21, 2010 - FDA Approves Once-Daily Memantine Formulation For Patients With Moderate To Severe Alzheimer’s Dementia.
BusinessWire (6/21, Jeffrey) reported that Forest Laboratories, Inc and Merz Pharmaceuticals GmbH "announced...they have received approval from the US Food and Drug Administration of an extended-release formulation of memantine hydrochloride (Namenda XR) for the treatment of moderate to severe dementia of the Alzheimer's type (DAT)." This "extended-release formulation is a 28-mg, once-daily dose of memantine; the twice-daily immediate-release formulation of the drug was approved in October 2003." Medscape noted that "safety and efficacy of the new formulation were established in a randomized, double-blind, placebo-controlled trial of 677 DAT patients who were already being treated with a cholinesterase inhibitor." The previously approved dose of memantine was 10mg twice daily, other than dose frequency no additional advantages of the new formulation were identified. Market exclusivity for the original formulation is due to expire in 2015.
June 22, 2010 - Pfizer Withdraws Cancer Drug Ten Years After Accelerated Approval For Lack Benefit And Safety Concerns.
The Wall Street Journal (6/22, Dooren) reported an FDA announcement that Pfizer Inc. has withdrawn Mylotarg (gemtuzumab ozogamicin) from the US market. Despite accelerated review and approval, 10 years ago, research has indicated that the medication was not effective and was linked to safety issues, notably a potentially fatal liver condition called veno-occlusive disease. The FDA said the rate of reports of the disease associated with the drug "increased during its time on the market." The Los Angeles Times (6/21, Healy) "Booster Shots" blog reported that "although Mylotarg received accelerated FDA approval in 2000, the agency required an additional clinical trial to demonstrate its safety and effectiveness." The required trial, which did not begin until 2004, “has shown higher levels of liver toxicity in patients than seen in early trials, with no benefits to patients." Researchers found that, "compared with AML patients on standard chemotherapy alone, those on Mylotarg were more likely to die." Bloomberg News (6/22, Larkin) reports that "Mylotarg...is the first medicine to be pulled off the market that was cleared through the Food and Drug Administration's accelerated approval program, the agency said today in a statement." According to Robert Kane, acting deputy director for safety in the FDA's Division of Hematology Products, "Accelerated approval still has a place in the approval process but it's also more important that we learn over the years that the whole development plan be set up well in advance." Reuters (6/22, Richwine), and MedPage Today (6/21, Smith) also covered the story.
June 22, 2010 - High-Deductible Health-Insurance Plans Attractive To Employers, But Draw Criticism.
The Washington Post (6/22, Andrews) reported, "Rising costs make" high-deductible health plans and health savings accounts linked to them "attractive to employers because they are cheaper than comprehensive coverage." Additionally, they "are a key element in 'consumer-driven health care.'" Critics complain that requiring people to pay more "for health care encourages them to cut back on care they need." These plans are also criticized as providing "a tax shelter for healthy, affluent people who can afford to sock money away and leave it there to grow."
June 22, 2010 - HHS Report Incites Concern Over Foreign Drug Trials.
The New York Times (6/22, A14, Harris) reports that the Department of Health and Human Services has completed a report finding: "80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites." The DHHS Inspector General "pointed out that the [FDA] was often unaware of foreign clinical trials as they were being conducted. As a result, federal regulators have no ability to ensure that patients in these trials are being protected while the research is continuing." Rep. Rosa DeLauro (D-CT) said, "By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health." The Times also noted that the FDA could not produce “clinical trial data for 29 of the 129 of the approved applications in 2008." This story was widely reported, appearing on over 100 news websites, including CBS News (6/23, Strickler).
June 22, 2010 - Osteoporosis Bisphosphonate Druvs May Be Associated With Lower Risk Of Invasive Breast Cancer.
MedPage Today (6/22, Bankhead) reported that "the risk of invasive breast cancer declined 30% to 40% among postmenopausal women using bone-preserving bisphosphonate drugs," according to two studies published online in the Journal of Clinical Oncology. In one study, researchers found that "bisphosphonate users in the Women's Health Initiative (WHI) had a 32% reduction in breast cancer risk during almost eight years of follow-up, while an Israeli study showed a 39% reduction in relative risk among women who took bisphosphonates for at least a year. Moreover, breast cancers among women taking bisphosphonates tended to have favorable prognostic characteristics."
June 22, 2010 – Lilly’s Humulin To Be Sold Through Walmart Pharmacies.
Reuters (6/22, Kelly) reported, "Eli Lilly & Co (LLY.N) will sell its Humulin insulin product in a co-branding deal with Wal-Mart Stores Inc (WMT.N) beginning in mid-September." The diabetes treatment will be sold "under the name Humulin Relion in 10 milliliter vials of Humulin R U-100, Humulin N, and Humulin 70/30 formulations." The Wall Street Journal (6/23, Kingsbury, Talley) notes that the deal is a shift for Walmart from its previous partnership with Novo Nordisk.
June 23, 2010 - Avandia Trial Sparks Dispute.
The Boston Globe (6/23, Rowland) reports on the 17 physicians "recruiting patients as subjects for a clinical trial testing the safety of Avandia [rosiglitazone], which was once the top-selling diabetes drug in the world, but has been the subject of controversy over warnings that it increases the risk of heart attack." Specialists, including some FDA officials, "contend that the drug is too dangerous to remain on the market and that the ongoing Avandia clinical trial is unethical," while defenders of the drug "say it has not been proven to be harmful." Meanwhile, on July 13, an FDA advisory panel "will publicly scrutinize Avandia safety issues, including whether the ongoing clinical trial should be suspended."
June 24, 2010 - Groups Lobbying FDA To Delay Generic Blood Thinner Have Ties To Brand Manufacturer.
The Wall Street Journal (6/24, Mundy) reported that some parties lobbying the FDA to delay approval of a generic version of the blood thinner Lovenox have undisclosed financial links to Sanofi-Aventis SA. The Journal identifies The Society of Hospital Medicine, the North American Thrombosis Forum, and researcher and professor Victor Tapson of Duke University Medical Center as being opposed to reviewing a generic alternative, and having ties to the brand manufacturer.
June 24, 2010 - Pfizer Will Not Proceed With Trial Of Antipsychotic Medication For ‘Pediatric Bipolar’ Disorder.
The Dow Jones Newswire (6/24, Gryta, Loftus) reports that Pfizer Inc. will not proceed with a study of the antipsychotic medication Geodon (ziprasidone) in young patients with bipolar disorder. However, the drugmaker still intends to seek pediatric bipolar approval of Geodon. In 2009, the FDA declined approval for this use and asked for more information. Because this and other antipsychotic medications are already widely used “off-label” in children, there may be no advantage for completing such a trial other than the additional 6-months marketing exclusivity. Additionally, the diagnosis of “pediatric bipolar disorder” is controversial and the American Psychiatric Association provides no diagnostic standard for such a condition.
June 24, 2010 - SSRIs, Amantadine May Harm Eyes Of Patients Over 65.
Two studies published in the June issue of Ophthalmology raise concerns about eye diseases and commonly used medications – specifically selective serotonin reuptake inhibitors (SSRIs) and long-term use of amantadine to treat Parkinson's disease. The first study of 18,784 cataract patients and 187,840 controls "found that SSRIs were associated with an increase in cataract risk by up to 39% in people older than 65 years." The second study, which included 169 participants, "showed corneal damage linked to the use of amantadine is dependent on the cumulative dose received."
June 24, 2010 - Merck Receives Marketing Approval For Combination Asthma Controller.
Forbes (6/24) reported, "Merck said Thursday that the U.S. Food and Drug Administration approved its inhaled asthma treatment Dulera." Dulera is a combination of previously approved inhaled asthma medicines, the steroid controller mometasone, and the long-acting bronchodilator formoterol. Like other formulation including a long-acting bronchodilator, this medicine will carry a warning of the potential for increased risk of death due to asthma. Nationwide availability is expected by the end of July. Triangle Business Journal (6/24, Vinluan), and Reuters (6/24, Sandle) also covered the story.
June 25, 2010 - Appeals Court Reviewing "Pay-To-Delay" Drug Deals Between Manufacturers.
Bloomberg News (6/25, Bliss, Decker) reports that FTC Chairman Jon Leibowitz wants a stop to the "pay-to-delay" practice of brand-name drugmakers paying generic manufacturers to keep their lower-cost version off the market, and "he could find out by August whether victory is possible." That is because "the US Court of Appeals for the Second Circuit in New York is considering whether to review an April decision by a three-judge panel of the court that upheld a 1997 deal between Bayer and Barr Pharmaceuticals, now a unit of Israel-based Teva Pharmaceutical Industries." The court is reviewing that agreement, in which "Barr dropped a patent challenge involving Cipro," and "in return, Bayer paid Barr $398 million over six years. The judges' panel urged a full-court airing, citing the 'exceptional importance' of the antitrust issues involved."
June 25, 2010 - Sanofi On Track To Double Its Diabetes Drug Sales, Company Says.
Bloomberg News (6/25, Torsoli) reports that Sanofi-Aventis SA "is 'well on track' to meet its target to double diabetes sales between 2008 and 2013, Pierre Chancel, who heads the company's diabetes division, said in an interview." Sanofi also "expects its best-selling product, the diabetes drug Lantus [insulin glargine], to maintain its lead among rival treatments." Chancel also stated the company "will continue with acquisitions and partnerships" to make its diabetes drug "pipeline more competitive."
