Trends-in-MedicineLynne Peterson,
Senior Writer
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2003
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Renal Research Institute International Conference on Dialysis: Advances in ESRD 2003
Summary: Nephrologists are starting to prescribe Amgen's Aranesp for pre-dialysis patients, and the outlook is for use to continue to ramp up, but reimbursement remains a problem. Use of Genzyme's Renagel is expected to continue to increase, limited only by patients' ability to pay for it, but doctors are anxious for a cheaper alternative. Doctors are willing to try Shire's Fosrenol (lanthanum) if it gets FDA approval, but they remain nervous about long-term safety. Amgen's oral calcimimetic, AMG-073, is not widely known, but doctors who are aware of it are very excited about it.
FDA: Reviewing New Drug Safety Issues - Quick Pulse
Summary: When FDA officials speak, people listen - or at least they should if they want to gain insight into the new drug approval (NDA) process. In an interview recently, a senior FDA official offered some perspective on how the agency deals with certain specific safety questions.
American Academy of Orthopedic Surgeons
Summary: It may not be the best of times, but it is still very good times for the orthopedic field. The number of patients needing - and getting - hip and knee replacements and spinal fusions continues to grow, and the outlook is for all of these procedures to continue to increase as Baby Boomers age. In addition, manufacturers have been able to steadily raise prices each year, and they are optimistic that this will continue at least for another year or two. There are no signs that CMS is about to trim reimbursement.
Cardiac Revascularization Therapy
Summary: More facts continue to trickle out about drug-eluting stents. It appears likely that Johnson & Johnson's sirolimus-eluting stent, Cypher, will not be available until April 2003 at the earliest. Guidant's paclitaxel-eluting stent, Achieve, was safe but failed to show efficacy in its pivotal Phase III trial, and the results have raised questions about whether Boston Scientific's paclitaxel eluting Express stent will be able to show efficacy in the pivotal TAXUS-4 trial. Experts are beginning to think (1) stent design really does matter and that (2) all rapamycin analogs are not the same. On the regulatory front, the FDA is calling for better science and promises to quickly process future drug-eluting stent submissions, but will not let companies cut development corners, and warned that expedited approval probably will not be granted.
Insomnia Update
Summary: Pfizer's Ambien and Wyeth's Sonata - along with benzodiazepines and antidepressants - are the most commonly prescribed medications for insomnia, but they are associated with sedation, rebound, abuse potential, dependence, and tolerance, and labeling for short-term use. Several new agents are in development to treat insomnia, including Sepracor's Estorra, Neurocrine Biosciences' Indiplon-IR, Takeda's melatonin agonist, and a sustained-release Ambien. However, none of these is generating much excitement, and experts doubt any agent acting on a benzodiazepine receptor - including Estorra and Indiplon -- will get a non-habituation label from the FDA. Doctors also are reserved on the outlook for Estorra because little data has been available.
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