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January 2012 Issues

Transcatheter Cardiovascular Therapeutics (TCT)
Summary:Commercial uptake of Edwards Lifesciences’ Sapien may be slower than some projections because hospitals initially will lose money on procedures and patients may be enrolled in clinical trials instead. Sites may do an average of <5 commercial procedures a month. ♦ The Danish STACCATO trial raised questions about the safety of the transapical approach to TAVR, but most cardiologists and surgeons remain convinced of the value of TA. ♦ Cardiologists continue to take a cautious view of Abbott’s MitraClip for mitral valve repair, wanting more trial data. ♦ The FDA is investigating longitudinal DES compression, which appears worse with Boston Scientific and Medtronic stents, but cardiologists believe it is a rare event and are not abandoning either Medtronic or Boston Scientific stents. ♦ The conclusion was that Accumetrics’ VerifyNow is great for research but not useful for individual patients. ♦ Renal denervation was described as potentially “transformational.” Medtronic has the lead, but other companies aren’t far behind. The FDA is concerned about safety and durability and cautioned that doctors can’t use just any off-the-shelf catheter for this.

December 2011 Issues

FDA's Oncologic Drugs Advisory Committee Recommends Approval of Affymax's Peginesatide for Dialysys Patients -- Quick Pulse
Summary:The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1, with one abstention, to recommend approval of Affymax’s peginesatide (formerly known as Hematide), an injectable erythropoiesis-stimulating agent (ESA), to treat anemia in chronic kidney disease (CKD) patients on dialysis.

Radiological Society of North America (RSNA) -- Quick Pulse
Summary:Our coverage of RSNA was limited this year because of a schedule conflict, so we focused on two main areas: the general capital spending environment for imaging and the outlook for 3D mammography (or tomosynthesis). Fourteen radiologists were interviewed. Overall, they said budgets are flat to down, and most purchases, if any, are replacements or upgrades.

FDA's Public Meeting on BioSimilar User Fees -- Quick Pulse
Summary:The FDA held a brief (less than 2-hour) public meeting on proposed recommendations for a biosimilar and interchangeable biological products user fee program (FY2013-2017). Only a handful of people (~50) attended the meeting, even if you include the speakers and FDA officials.

FDA Advisory Committee Rejects CardioMEMS' Champion Heart Failure Monitoring System -- Quick Pulse
Summary:The FDA’s Circulatory System Devices Advisory Committee recommended against approval of CardioMEMS’ Champion heart failure monitoring system, an implantable wireless device that measures pulmonary artery (PA) pressure in patients who have been hospitalized with New York Heart Association (NYHA) Class III heart failure (HF). The permanent device has a battery-free capacitive pressure sensor/monitor implanted in the pulmonary artery, a transvenous catheter delivery system, and an electronics system to receive the data and put it in a database for review.

FDA Advisory Committee Recommends Approval of Pfizer's Inlyta (axitinib) for Advanced Kidney Cancer -- Quick Pulse
Summary:The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 13-0 to recommend approval of Pfizer’s Inlyta (axitinib) as a second-line therapy for patients with advanced renal cell carcinoma (RCC), saying that while the drug has toxicities, those toxicities are different from approved tyrosine kinase inhibitors (TKIs) and that Inlyta is non-inferior to an approved TKI.

American College of Rheumatology
Summary:The promise of oral RA therapies is extremely attractive, but doctors plan to use them cautiously until there are more safety data, so they are unlikely to have a big impact on the anti-TNF drugs in their first year. Vertex’s VX-509 looked efficacious and perhaps safer than Pfizer’s tofacitinib. Doctors were somewhat concerned about tofacitinib lipid data but dismissed questions about creatinine elevations. ♦ Pricing of anti-TNF drugs as well as new oral RA agents is a concern. ♦ There appeared to be little interest in Crescendo Bioscience’s Vectra DA biomarker test. ♦ Rheumatologists plan to use the new subcutaneous formulation of Bristol-Myers Squibb’s Orencia, but mostly for patients already on the IV formulation. Orencia failed in a Phase II trial in lupus nephritis, and investigators are worried about the drug’s prospects in that disease. ♦ Doctors are using little of Human Genome Sciences and GSK’s Benlysta for SLE because they can’t figure out the appropriate patients and are concerned that it doesn’t work very well. ♦ Phase II data on Celgene’s apremilast in ankylosing spondylitis were disappointing. ♦ Physicians were puzzled by what was omitted from the new ACR guidelines for RA – any mention of steroids. ♦ Omega-3 fish oils got some support at ACR, but prescription versions were dismissed.

FDA's Advisory Committee Approves Retreatment Trial Design for Salix's Xifaxan in IBS-D -- Quick Pulse
Summary: The FDA’s Gastrointestinal Drugs Advisory Committee gave the green light to Salix Pharmaceuticals’ proposal for a retreatment trial for Xifaxan (rifaximin) in patients with irritable bowel syndrome with diarrhea (IBS-D), despite concerns about the trial design, the drug’s efficacy, and the unknown mechanism of action. Xifaxan already is approved for treatment of hepatic encephalopathy and travelers’ diarrhea. It would be the first antibiotic approved for IBS-D patients.

November 2011 Issues

American Academy of Ophthalmology (AAO)
Summary: Retina specialists are excited about Regeneron’s Eylea because it offers a longer time between injecions than current VEGF inhibitors. Doctors plan to do treat-and-extend dosing on an every 6-8 week basis. Eylea is likely to replace Roche/Genentech’s Lucentis quickly and almost completely if it is priced = Lucentis. If it is priced at a premium, patients doing well on Lucentis are less likely to be switched. ♦ Retina specialists have not shifted away from Roche/Genentech’s Avastin for wet AMD because of endophthalmitis resulting from compounding pharmacy contamination of the product, and the VA lifted its temporary ban on Avastin. ♦ There is still some room for use of anti- VEGFs to increase in RVO and DME, primarily among community retina specialists. ♦ The expected new data on radiation therapy for wet AMD were not presented. ♦ In glaucoma, the focus is on generics, generics, generics. ♦ An FDA reorganization is likely to slow approval of any new ophthalmic drugs. ♦ Femtosecond lasers for cataract surgery – both broad-based and single-procedure systems – are a hot new technology, but reimbursement remains a question.

October 2011 Issues

European Society of Cardiology (ESC)
Summary: Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban) was the talk of the meeting, and the data looked very good, but doctors warned not to count Boehringer Ingelheim’s Pradaxa and, especially, Johnson & Johnson/ Bayer’s Xarelto out yet, and they still see a large role for warfarin for at least the next 5-10 years. Despite only preclinical data, there was great optimism about Portola’s PRT-064445 antidote for Factor Xa inhibitors. ♦ CETP inhibitors are alive, but cardiologists are reserving judgment until there are more data. ♦ Omega-3 fish oils – Abbott’s Omacor and Amarin’s AMR-101 – got a push at ESC, but doctors had little interest, and the differences appeared more marketing messages than real. ♦ Platelet reactivity testing, particularly Accumetrics’ VerifyNow point-ofcare test, is growing but slowly. ♦ Use of Abbott’s MitraClip for mitral valve repair is growing but the learning curve, difficulty, and patient selection remain issues. FDA approval is uncertain, and if it is approved, it is still likely to be a relatively niche product. ♦ Early data on longer term durability of percutaneous aortic valves looks good.

September 2011 Issues

FDA's Advisory Committee Recommends Approval of J&J's Xarelto for Stroke Prevention in Atrial Fibrillation -- Quick Pulse
Summary: The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2, with one abstention, to recommend approval of Johnson & Johnson’s application for an atrial fibrillation indication for once-daily Xarelto (rivaroxaban). The vote was in stark contrast to the recommendation of the FDA reviewers who recommended that the drug not be approved and that the Agency issue a complete response letter. However, the panel did appear to agree with the reviewers that, if approved, Xarelto should not be a first-line drug, and the panel recommended a study of how to transition patients from Xarelto to warfarin, preferably before the drug is approved.