October 2005 Issues

ICD Conference

Summary: The FDA/HRS conference on ICD recalls didn’t produce any consensus, but it opened a dialogue, and it gave all sides – electrophysiologists, FDA officials, the public, and device company executives – an opportunity to have a say. It was clear everyone wants to know what should trigger a recall and who should set that level, but finding a consensus may be difficult. The good news was that the process of discussion and negotiation is underway.

Summary: Takeda’s PROactive trial of high dose (45 mg) Actos vs. placebo missed its primary endpoint. Actos did show a 16% reduction in the composite of death, stroke, and MI, but it was also associated with a doubled risk of heart failure. European doctors said they would increase their use of TZDs after the trial, but TZD use will still be very limited. ♦ European doctors are not very excited about Lilly/Amylin’s Byetta unless it is proven to increase beta cell mass. There were no new data on exenatide-LAR, but it was described as “very powerful.” ♦ Byetta has an advantage in efficacy and weight loss over DPP-4s (like Novartis’s vildagliptin), but it also is an injectable with a lot of nausea, so sources believe there will be a role for both agents. . There was little enthusiasm for inhaled insulins at EASD, and sources predicted that European approval may be slow for Pfizer/Nektar/Sanofi-Aventis’s Exubera and other products. ♦ Phase III data on Lilly’s ruboxistaurin in diabetic retinopathy looked very good.

Multiple Sclerosis Update

Summary: Results were positive from the BENEFIT trial of a high dose of Schering AG/Berlex’s Betaseron/Betaferon in early MS, but Doctors said this may not change their prescribing practices. ♦ Novartis’s oral fingolimod (FTY-720) looks promising as an oral therapy for MS. ♦ Schering AG/Genzyme’s Campath has safety issues, but it is very effective, and doctors believe it will find a role. ♦ Protein Design Lab’s daclizumab and Serono’s Myelinax (oral cladribine) are both worth watching. ♦ The spectacular efficacy of Biogen Idec/Elan’s Tysabri held up at two years in the SENTINEL trial. Tysabri was a hot topic at the meeting, with most doctors predicting it will return to the market. European doctorswere taking a much more conservative approach to possible future use than U.S. doctors. There is no predictive test, just a diagnostic test, for PML or JC virus.

Update on Opthalmology in Europe and Refractive Surgery Trends in the U.S.

Summary: Cataract surgery has slowed in Europe, but it has picked up somewhat in the U.S. with the new multifocal lenses. ♦ LASIK volume is flat in Europe and in a fall slump in the U.S. ♦ IntraLase’s femtosecond laser flap-maker is finding converts among European refractive surgeons. ♦ There was a lot of excitement in Europe over new AMD therapies, and doctors are quietly starting to use Genentech’s Avastin off-label. ♦ Phase III data on Lilly’s ruboxistaurin indicate it is effective and safe in treating diabetic retinopathy. Lilly plans to submit the drug this year, and it wouldn’t be surprising to see the drug get fast-track approval from the FDA.

European Society of Cardiology

Summary: The European Society of Cardiology meeting is always a good way to get a jump on what's likely to come up at the fall TCT or American Heart Association meetings, and this year was no exception. There was news on drugs in development for atrial fibrillation, anticoagulants (Factor Xa inhibitors, direct thrombin inhibitors and anti-thrombotics), the struggle to develop new heart failure medications, the ASCOT-BPLA hepertension trial, other drugs under investigation to treat hypertension, and more. On the device side, this report takes a look at developments with respect to defibrillators, drug-eluting stents, PFO closure, and percutaneous valves.