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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Eyecare Update II
Summary: Optometrists are excited about Allergan's Restasis, which may expand the market, but use will be dictated by formulary inclusion and cost. Pfizer/Pharmacia's Xalatan is continuing to lose market share, but slowly, to Allergan's Lumigan and Alcon's Travatan. Johnson & Johnson/Vistakon has the most momentum in contact lenses, but CooperVision also is likely to be a winner. Doctors could find little good news for Bausch & Lomb. If a generic brimonidine becomes available, doctors expect strong pressure from managed care and Medicaid to switch patients to that from Allergan's Alphagan-P. Refractive surgery (LASIK) procedures have not picked up, and no improvement is in sight.
FDA Review of the Safety of Rheumatoid Arthritis Therapies
Summary: Abbott is likely to have a CHF warning added to the Humira label. J&J and Amgen will get a lymphoma warning, and it's possible J&J will get the worst wording on its label. J&J officials appeared a bit nervous at the meeting, and the potential competitive disadvantage of a specific lymphoma label may have been the reason. Amgen appeared to avoid having its TB/infection warning increased from a bold warning to a black box.
The American Academy of Asthma, Allergy and Immunology (AAAAI)
Summary: Despite pressure from HMOs to use OTC Claritin, most allergy specialists are still prescribing brand antihistamines, and Aventis' Allegra is the winner. Merck's Singulair is starting to catch on in allergic rhinitis, with use expected to increase. A study of Idec Pharmaceuticals IDEC-152 for allergic rhinitis was disappointing, showing safety but no efficacy. A study of Inspire Pharmaceuticals' P2Y2 for allergic rhinitis, INS37217 showed safety and "a hint" of efficacy. Genentech/Novartis/Tanox's anti-IgE, Xolair, generated a lot of attention. Doctors consider it safe, effective, and likely to be approved this year. They plan to use Xolair for an average of 7% of their patients, which includes high off-label use, particularly for food allergies but not for allergic rhinitis. Doctors expect managed care to cover Xolair, but cost will be a limiting factor. Tanox's TNX-901 looks promising to treat peanut allergies, but Xolair may be developed instead by Genentech-Tanox-Novartis.
FDA Oncologic Drugs Advisory Committee
Summary: In the future, the FDA is likely to require companies to begin Phase III or IV confirmatory studies prior to granting accelerated approval, and the FDA will put companies under a spotlight if they don't complete those confirmatory trials in a timely manner. The FDA has the authority to withdraw drugs that have been granted accelerated approval if they don't complete a positive confirmatory trial, but the agency has no plans to do so and probably won't do so -- unless safety becomes an issue. The FDA also is unlikely to withdraw a drug that fails a confirmatory trial if safety is not an issue. ODAC is likely to be more reluctant to recommend accelerated approvals in the future.
Intensity Modulated Radiation Therapy Update
Summary: IMRT use is growing, and the trend is likely to continue. Eventually, sources expect almost everyone to convert to IMRT. Hospitals are not postponing IMRT purchase decisions, but IMRT purchasing decisions and implementation take much longer than many sources expected. IMRT is labor intensive, and many sites are currently under-utilizing the technology. Hospitals are willing to mix and match accelerators and IMRT planning systems, and sites are comparing different systems before making a choice. Varian appears to be losing market share, especially to ADAC due to features, cost and perhaps service.
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