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© 2002
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Cardiovascular Radiation Therapy VI and Restenosis Forum II
Summary: The pivotal trial of Johnson & Johnson’s sirolimus-eluting stent, Cypher, is not expected to be stopped early, but the FDA could make a quick judgment on the product once the trial is complete – provided there are no manufacturing issues. Malapposition and edge effect concerns do not appear to be a big issue, but the FDA is concerned about the deaths in a European in-stent restenosis trial, so it appears that J&J initially may get a somewhat restricted label. Competition continues to heat up, but doctors remain cautious if not dubious about the outlook for paclitaxel. Medtronic is rumored to have struck a deal with Novartis to develop everolimus, and the regulatory path for a non-approved drug appears to have gotten easier, making this a stronger – though late -- potential entrant. Doctors are now suggesting that patients who have had brachytherapy may not be candidates for drug-eluting stents.
American Academy of Dermatology Psoriasis Update
Summary: Dermatologists have started using Johnson & Johnson’s Remicade and Immunex’s Enbrel off-label to treat psoriasis, and the data on these agents looks very good. The outlook for other biologic agents in psoriasis is more questionable. Genentech/Xoma’s Xanelim has a problem with rebound on and off drug, and Biogen’s Amevive depresses CD4 counts. Both Amevive and Xanelim are likely to face intense regulatory scrutiny.
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