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
No articles may be reproduced without written permission of the publisher.
Return Home
American Diabetes Association
Summary: Amylin's Symlin and its GLP-1, exenatide, are both likely to gain FDA approval. Usage will depend on how much of the weight loss is due to nausea, which is significant but declines over time. The outlook for a long-acting version, LAR, and an anti-obesity drug, PYY3-36 is still questionable. DPP-4 inhibitors look promising, but there are safety concerns. Novartis's LAF-237 lowers HbA1c but not much, and it did not cause weight loss. Inhaled insulin can't be used by active smokers and causes antibodies, but the antibodies do not appear to have clinical significance. Several dual PPARs have failed, and most of the others appear to be me-too drugs, except perhaps GlaxoSmith-Kline's PPARpan. Early data indicate Johnson & Johnson's Topamax and Avanir's Neurodex may be helpful in diabetic neuropathy and GlaxoSmithKline's Avandia may prevent restenosis.
Association of Professional Sleep Societies (APSS)
Summary: Cephalon made a strong case for expanded labeling for Provigil to treat Shift Work Sleep Disorder. TAK-375 may be the least effective hypnotic, and the data is positive mostly for objective, not subjective, measures, but it is unlikely to have the limitations of the benzodiazepines. Efficacy data for Sepracor's Estorra was impressive, but questions remain about safety. Menstrual cycles and estradiol levels were monitored in one trial, but officials said the completed toxicology studies are clean. Neurocrine Bioscience's Indiplon-IR induces sleep well, and the company is hoping the MR formulation will maintain sleep. Use of Orphan Medical's Xyrem in narcolepsy is growing, and it may be useful in fibromyalgia.
New Clinical Drug Evaluation Unit (NCDEU) Meeting
Summary: The attention-getters at the meeting were: Lithium, Corcept Therapeutics' mifepristone (RU-486), and Forest Labs memantine. Despite the weight gain issue, doctors are not abandoning Lilly's atypical antipsychotic Zyprexa. They are trying Bristol-Myers Squibb's Abilify, seem to like it and find it comparable to Zyprexa, but they noted some agitation associated with Abilify. Sources are not at all optimistic about the outlook for Merck's Substance P. Lilly's Strattera for ADHD has not impressed sources as superior to other ADHD drugs. The FDA is putting increased emphasis on dose responses and finding the best, not the highest, dose. The agency may start requiring longer term data for labeling, is unlikely to accept surrogate endpoints, and will continue to refuse to allow superiority claims.
Biogen's Antegren - Quick Pulse
Summary: Biogen/Elan's Antegren, the first in a new class of humanized monoclonal antibodies (selective adhesion molecules), is currently in Phase III trials in both multiple sclerosis (MS) and Crohn's Disease. Gastroenterologists and neurologists were questioned about the outlook for Antegren, particularly in Crohn's Disease.
1879 Avenida Dracaena, Jensen Beach, FL, 34957, 772-334-7409, Fax 772-334-0856
Email webmaster about site: snyderk577@aol.com
