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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November 2002 issues (click links below for full story)
National Institute of Health: Scientific Workshop on Menopausal Hormone Therapy
Summary: More and more experts are weighing in on the side of a very limited role for hormone therapy - as short-term therapy for severe symptoms of menopause (hot flashes), not as a preventive for anything. In this environment, hormone therapy use in general - and Prempro use in particular -- is likely to continue to decline. Many clinicians have been slow to accept this message, but the voices are getting more common and louder, and additional data and analyses are expected that should reinforce the message. Although the WHI findings were only with Premarin and Prempro, experts and regulators generally agreed that the findings must be considered to apply to other hormone products until and unless they are shown to be safer.
The Safety of Astrazeneca'a Iressa
Summary: AstraZeneca's Iressa has been linked to 125 cases of interstitial pneumonia and 39 deaths in Japan, leading to a label change but not market withdrawal. AstraZeneca has downplayed the significance of these reports, and U.S. oncologists do not appear to be not worried about this, with most suggesting it is something unique to Japan. However, FDA officials are likely to be more concerned, and they may require another trial before approving Iressa.
American College of Rheumatology
Summary: Abbott's Humira (D2E7) is poised for a strong launch, and it is likely to take share from Remicade but even more from Enbrel. The number of patients waiting for Enbrel supply to improve may be far smaller than Amgen estimates, and the company's credibility has been hurt with some doctors. The Phase II data was positive for Bristol-Myers Squibb's oral CTLA4Ig. Idec's Rituxan looks promising, with an effect that lasts six-months, but safety remains a concern, and the FDA is likely to require long term (3 year) trials. Preclinical data on Scios' p38-MAP kinases looks promising, but it is still very early. Use of Merck's Vioxx is expected to continue to decline due to publicity about cardiac toxicity, with Pfizer's Bextra picking up share.
Drug Eluting Stents Move a Step Closer
Summary: An FDA advisory panel voted 8 to 0 on October 22, 2002, to recommend approval of the Cypher drug-eluting stents. The panel recommended only about one-fourth of the sizes that J&J requested, but label expansions will not require large, prospective trials. Brachytherapy is likely to be contraindicated in patients with a drug-eluting stent. The PDUFA date has been pushed back to April 21, 2002, because a Major Deficiency letter was issued on manufacturing issues, though the FDA is working with J&J to resolve this sooner. Final approval will depend upon resolution of several issues that may delay action on this product: a Major Deficiency letter, other manufacturing issues, shelf life and labeling (which an FDA official said the agency is "a fair ways away" from finalizing).