After Study Questions Effectiveness Of Drug For Preterm Births, FDA Panel Recommends Removing It From Market
Although the FDA doesn't have to follow the guidance, the vote could call into question the use of the medication, which to this point has been viewed as standard treatment. Other pharmaceutical news looks at Alzheimer's research, as well as a recall of a generic version of Xanax.
FDA Panel Recommends Removing Makena For Preventing Premature Births
A Food and Drug Administration advisory panel recommended that a controversial treatment for preventing premature births should be withdrawn from the market after reviewing a clinical trial that indicated the medicine, called Makena, is not effective. The agency is not required to follow the recommendations of its panels, but the 9-to-7 vote calls into question the future of a medication that has been the standard of care across the U.S. since it was approved eight years ago. At the time, the FDA required a followup study as a condition of endorsing the medicine under its accelerated approval process. (Silverman, 10/29)
The Wall Street Journal:
FDA Committee Recommends Withdrawing Treatment To Prevent Preterm Births From Market
A U.S. Food and Drug Administration advisory committee recommended Tuesday that the standard treatment to prevent women from having another preterm birth, Makena, be withdrawn from the market in a 9-to-7 vote following a public hearing. The FDA approved the treatment, now made by AMAG Pharmaceuticals Inc., in 2011, contingent upon completing a follow-up study. That study, published last week in the American Journal of Perinatology, found that the weekly synthetic progestin injections didn’t decrease recurrent preterm births in women who took it versus a placebo. (Reddy, 10/29)
FDA Advisors Recommend Yanking Approval Of Preterm Birth Prevention Drug After It Flops In Crucial Study
Panel members who voted to withdraw approval — even the patient representative tearfully did so — said they agonized over the decision. For one thing, nothing else has proven effective at preventing preterm birth, the leading cause of newborn death and disability. For another, hydroxyprogesterone acetate has become standard treatment, recommended by medical societies, for women with a previous preterm birth. Finally, the drug can be ordered from compounding pharmacies that custom make it for about $20 a dose, so taking Makena’s much-pricier product off the market will not necessarily change medical practice. (McCullough, 10/29)
FDA Advisers Suggest Removing Premature Birth Drug
Nine of the 16 panel members voted to withdraw approval, while seven said the drug should stay on the market while another trial is conducted. No one voted to leave it on the market without a trial. Depending on the FDA’s decision, the company behind Makena, AMAG Pharmaceuticals, or any other company that tries to conduct a new trial for a drug, will likely have a hard if not impossible time recruiting new patients, panelists said. There are many ethical concerns about testing new drugs on pregnant women given the risks of birth defects, and women looking for treatment might not want to risk being randomized into a placebo arm of a trial. (Siddons, 10/29)
Taking Stock Of Alzheimer’s Research, Biogen, And The Amyloid Hypothesis
Is seeking a cure for Alzheimer’s disease hopeless? Is Biogen’s recent decision to repurpose a failed Alzheimer’s trial an elaborate parlor trick? And what about Pfizer’s decision to walk away entirely from neuroscience entirely? The unanswered questions in the field of Alzheimer’s research can make the average observer’s head spin. So STAT’s executive editor Rick Berke pressed a panel of experts on those questions and more Tuesday in Washington as part of the Milken Institute’s Future of Health Summit. (Florko, 10/29)
The New York Times:
Recall Of Generic Version Of Xanax Is Announced By F.D.A.
The Food and Drug Administration has announced a nationwide recall of a batch of alprazolam, a generic version of Xanax, because of potential contamination. The manufacturer, Mylan Pharmaceuticals, said Friday that the voluntary recall was because of the possible presence of a foreign substance. The company had not received reports of problems related to the tablets, but “the remote risk of infection to a patient cannot be ruled out,” it said. A Mylan spokeswoman did not immediately respond to questions about what the contaminant was. (Zraick, 10/29)