October 2009 Issues

FDA Advisory Committees Recommend Approval of Purdue’s Reformulated Oxycontin -- Quick Pulse

Summary: The FDA’s Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly recommended approval of Purdue’s reformulated OxyContin (oxycodone controlled-release) by a vote of 14-4, with one abstention. The FDA had previously turned down the new OxyContin, but panel members agreed that the data were much improved, though they asked for a post-marketing study due to continued concerns about safety. Although the panel expressed concern about the continued misuse and abuse of OxyContin, it saw the reformulated drug as the lesser of two evils.

ECCO-15 – ESMO-34 The 15th Congress of the European Cancer Organization (ECCO) and The 34th Congress of the European Society for Medical Oncology (ESMO)

Summary: The positive news:  ♦ Amgen’s denosumab is safe and effective for skeletal-related events. ♦ Amgen’s Vectibix is effective first-line in metastatic colorectal cancer but only if the patients are KRAS-wild type. ♦ Roche/Plexxikon’s PLX-4032 improves survival in metastatic melanoma. ♦ No new safety signals were seen with Roche’s Tarceva in non-small cell lung cancer. ♦ Regional hyperthermia improves mortality in sarcoma patients. The negative and mixed news: ♦ Bayer/Onyx’s Nexavar improves survival in metastatic breast cancer, but side effects are a concern. ♦ No first-line benefit was shown for Lilly/Bristol-Myers Squibb’s Erbitux in metastatic colorectal cancer. ♦ Roche’s Avastin showed no survival benefit in malignant melanoma.  

European Association for the Study of Diabetes (EASD)

Summary: Endocrinologists don’t believe the incretin mimetics cause pancreatitis, so FDA warnings are not dampening their enthusiasm. ♦ Doctors are dubious that long-acting insulin analogs promote tumor growth. Novo Nordisk is trying to distance Levemir from Sanofi- Aventis’s Lantus, suggesting that if there is a problem, it is with Lantus, not Levemir. ♦ Doctors are not convinced that Novo Nordisk’s GLP-1, Victoza (liraglutide), causes thyroid cancer and dismissed C-cell hyperplasia as an animal, not human, issue. ♦ Bristol-Myers Squibb’s DPP-4, Onglyza, was generating little excitement, but it is expected to expand the DPP-4 market which currently accounts for <10% of patients on oral diabetes drugs, especially in lieu of sulfonylureas, rather than taking share from Merck’s Januvia. The key limitation on DPP- 4s is cost. ♦ New drug ‘fatigue’ has settled on the diabetes community, and there is no excitement about new classes of drugs. Bristol-Myers Squibb/AstraZeneca’s dapagliflozin, the most advanced SGLT-2, has only modest efficacy, and doctors are very concerned about genitourinary infections, though there is no evidence they will lead to pyelonephritis. ♦ Roche’s once-weekly GLP- 1, taspoglutide, may be the category killer. Doctors speculated it may be as efficacious as Victoza, better than Amylin/Lilly’s Byetta, and more convenient than either.  

International Headache Congress (IHC) Hosted by the American Headache Society (AHS)

Summary: Allergan’s Botox migraine data looked positive, but doctors are very skeptical about the results. Still, patients are likely to ask for it, and it will be used at least as a last resort for those willing to pay for it or able to convince their insurance companies to cover it. ♦ MAP Pharmaceuticals’ Levadex, a self-administered, orally inhaled form of dihydroergotamine, seems to be effective, but doctors still want more data. ♦ Merck’s telcagepant, a calcitonin generelated peptide (CGRP) antagonist, works well, but enthusiasm was muted due to some confusion about whether or not the company has put it on hold due to questions about liver toxicity. ♦ NuPathe’s Zelrix, an iontophoretic transdermal sumatriptan patch, appears to work and is well tolerated by patients particularly those bothered by stomach problems and nausea associated with other treatments.

FDA Advisory Panel Unanimously Recommends Approfal of Auxilium's Xiaflex for Advanced Dupuytren's Disease -- Quick Pulse

Summary: The FDA’s Arthritis Advisory Committee voted unanimously (12 to 0) to recommend Auxilium Pharmaceuticals. Xiaflex (AA4500/collagenase clostridium histolyticum or CCH) for the treatment of advanced Dupuytren’s disease. Xiaflex is a novel, first-in-class, orphan-designated biologic injectable for the non-surgical treatment of Dupuytren’s contracture, a disorder caused by an abnormal buildup of collagen in the hands, eventually causing the fingers to bend and be unable to extend. The panel agreed that the benefits clearly outweighed any risks, and several members spoke of the compelling testimony of public witnesses who said that the procedure changed their lives.