May 30, 2010 - Drugmaker Settlements May Not Decrease Marketing Abuses.
Time (5/30, Stier) reported that despite praise from the Justice Department of the $520 million dollars settlement paid by AstraZeneca "as a result of the off-label marketing of its blockbuster anti-psychotic drug Seroquel [quetiapine fumarate]" Critics point out that “even such large fines have yet to make a serious dent in recurring marketing abuses." Time observed that, "Since companies can roll the costs of such fines into future drug prices, the penalties become just another cost of doing business.”
May 28, 2010 – Program To Improve Prescribing Practices For Patients With Hypertension.
HealthDay (5/28, Dotinga) reported on an Academic Detailing study involving face-to-face interactions “to review current research and guidelines, doctors made small improvements in the way they prescribed medicine for patients with high blood pressure." The study was published in the Archives of Internal Medicine. Researchers found that after review of treatment guidelines, physicians “appeared to be more likely to prescribe certain blood pressure medications as recommended, with 8.7 percent prescribing the thiazide-type diuretics compared to 3.9 percent in the general population."
June 2, 2010 - FDA Approves Denosumab To Lower Fracture Risk In Postmenopausal Women.
The Wall Street Journal (6/2, Gryta), and Bloomberg News (6/2, Waters) reports that the Food and Drug Administration has approved Amgen's Prolia (denosumab) injectable medication for postmenopausal women with increased risk of fractures due to osteoporosis. Amgen is to create a clinical monitoring program to follow more than 4,500 women taking denosumab The decision immediately follows marketing authorization by the European Union according to Reuters (6/2, Berkrot).
June 2, 2010 – Low-Dose Rosiglitazone And Metformin May Slow Type 2 Diabetes Progession.
The Los Angeles Times (6/2, Maugh) "Booster Shots" blog reported, "A combination of low doses of the diabetes drugs Avandia [rosiglitazone] and metformin can reduce the progression to type 2 diabetes by two-thirds in people who are at high risk of developing the disease," according to a study published online June 3 in The Lancet. In fact, "the benefit is greater than with either of the drugs used alone, and the combination has fewer side effects." For the study, researchers at the University of Toronto "enrolled 207 patients with impaired glucose tolerance, randomly assigning half to take the combination and half to take a placebo," then followed them for almost four years.
HealthDay (6/2, Gordon) reported that not only did the study find "that the risk of developing type 2 diabetes was reduced by two-thirds in those taking the drug combo compared to those on placebo," but also that "using half of the maximum dose was extremely effective for preventing type 2 diabetes." Moreover, "the drug combination appeared to counteract the weight gain that's common with Avandia therapy alone," and with relatively few side effects. "The dosages used in the study were 2 milligrams of Avandia plus 500 milligrams of metformin," WebMD (6/2, DeNoon) reported. But, in an email to WebMD, Steven E. Nissen, MD, of the Cleveland Clinic Foundation, said, "There is no evidence whatsoever that lower doses of [Avandia] are 'safe.'" He added, "Any suggestion that serious cardiovascular toxicity can be avoided by using a small dose represents pure speculation at best."
According to MedPage Today (6/2, Fiore), an accompanying editorial also "cautioned that the 'larger issues that have cast doubt on use of drugs to prevent diabetes are not addressed by the'" study. Reuters (6/3, Fox) also covered the story.
June 3, 2010 - FDA Advisory Panel Recommends Against Motavizumab Approval.
Bloomberg News (6/3, Larkin) reported, AstraZeneca Plc's MedImmune Unit "failed to win a US panel's backing to introduce an improved version of its $1 billion-a-year medicine” which is intended to reduce hospitalization for Respiratory Syncytial Virus. Motavizumab "was designed to replace Synagis [palivizumab], an older drug" that helped treat "children at risk for complications from respiratory syncytial virus." Although Synagis will lose "patent protection in 2015," the FDA advisers "recommended against approval of" the newer drug "in a 14-3 vote."
In a "report to the advisory committee," the Washington Business Journal (6/2, Sinha) reported that "a preliminary FDA review team raised three concerns with motavizumab, including technical aspects of the testing as well as the fact that the newer drug candidate had three times as many incidents of non-fatal hypersensitivity side effects in patients when compared with Synagis." Of note, the "process for gaining approval for motavizumab had already been delayed by several years after MedImmune decided to conduct a third clinical test and then again after the FDA had asked for additional data on top of the first drug application, which the local subsidiary of London-based AstraZeneca PLC had filed in January 2008."
Reuters (6/3, Heavey) reports. MedImmune continues “to believe motavizumab offers a meaningful clinical benefit to patients at high risk for a very common and serious illness." Sales of Synagis were impacted negatively last year by changes in national recommendations for use.
June 2, 2010 - FDA Accepts New Drug Application To Treat Obesity.
The San Diego Union-Tribune (6/2, Calbreath) reported, "San Diego's Orexigen Therapeutics said Tuesday that the Food and Drug Administration has accepted a new drug application for Contrave [naltrexone SR/bupropion SR], its proposed treatment for obesity -- becoming the latest of three drugs to enter the final stage of the agency's approval process." The FDA "is expected to decide on treatments from" Arena Pharmaceuticals and Vivus "in late October," though the "agency hasn't announced when it will have one of its panels review the drugs, prompting speculation that all three drugs might face review in September."
June 2, 2010 - GlaxoSmithKline Reaches Settlement In First Avandia Case.
The Wall Street Journal (6/2, Stovall) reported that, according to a spokeswoman from GlaxoSmithKline PLC, the drugmaker has reached a settlement in the very first Avandia [rosiglitazone] case scheduled to have been tried in Philadelphia, PA on June 1. No details of the settlement were disclosed. Reuters (6/2, Hirschler) reported that GSK still has not settled a pending multi-district suit scheduled to go to trial in October in a federal court.
June 3, 2010 - FDA Requests Revision Of Some LABA Warning Labels.
The Triangle Business Journal (6/3, Gallagher) reports, "The US Food and Drug Administration has directed drugmakers...to revise the warning labels on some of their asthma treatments." The agency said that "new warnings are needed on long-acting beta-agonists [LABAs], including GSK's Serevent [salmeterol] and Advair [fluticasone propionate], because the medication could result in severe asthma symptoms that lead to hospitalizations in children and adults or even result in death." The letters mark the eighth time the FDA has used its new power to change drug labeling since Congress granted it that authority in 2007. FDA officials stated that they wanted to see the overall use of combination products decrease as they are only needed by the most severely affected asthma patients. Dow Jones Newswire (6/3, Dooren) also covers the story.
June 4, 2010 - One In Five High School Students May Abuse Prescription Medications.
A survey (pdf) from the Centers for Disease Control and Prevention which "shows one in five high school students have taken a prescription" medication not obtained from a physician. Medications of abuse included pain medicines and medications for attention-deficit/hyperactivity disorder "used as study aids." The 2009 National Youth Risk Behavior Survey also found that "twelfth-graders had the highest likelihood of prescription" medication "abuse, at 26 percent, and ninth-graders had the lowest, at 15 percent," the CNN (6/3, Landau) "Paging Dr. Gupta" blog reported. HealthDay (6/3, Reinberg) reported that the survey of some "16,460 high school students" also revealed that "the abuse of prescription" medications "was widest among whites at 23 percent, followed by Hispanics at 17 percent, and black students at 12 percent."
The survey also asked students about drug and alcohol abuse, WebMD (6/3, Hendrick) reported. It found that "72% of high school students said they had used alcohol," while "37% said they had used marijuana, 6.4% said they had used cocaine, 4.1% said they had used methamphetamine, 6.7% said they had used ecstasy, 2.5% had used heroin, and 8% had used" hallucinogens, "such as LSD or mescaline."
June 4, 2010 - Afinitor Meets Goals In Late-Stage Study.
Novartis AG announced that its drug Afinitor [everolimus] met key treatment goals in a late-stage study involving patients with pancreatic neuroendocrine tumors. The research is scheduled to be presented at the American Society of Clinical Oncology annual meeting.
June 4, 2010 - FDA Approves Monistat Generic.
Perrigo Co. said Thursday the Food and Drug Administration approved the company's generic over-the-counter version of Johnson & Johnson's vaginal cream Monistat [miconazole]. Perrigo "was the first to file an application to make a generic version of the yeast infection treatment and the resulting patent litigation filed by Johnson & Johnson was previously dismissed."
June 4, 2010 - Amgen May Seek New Indication For Prolia Following This Week's Approvals.
The Wall Street Journal (6/4, Winslow) reported on the recent approval of Amgen's Prolia [denosumab] to treat women with osteoporosis after menopause in both the US and Europe. The Journal noted that if the drug is also approved for patients with cancer, some analysts expect sales could exceed $3 billion by 2015. Researchers at the American Society of Clinical Oncology' meeting presented new data on the drug's ability to delay fractures and other complications related to prostate cancer that has spread to the bone.
