February 2010 Issues

Another FDA Risk Program: This Time for Asthma Medications -- Quick Pulse

Summary: The FDA wants the use of long-acting beta agonists (LABAs) to go down. To ensure that happens, the Agency has imposed a new Risk Evaluation and Mitigation Strategy (REMS) for these drugs, warning that they .should never be used alone in the treatment of asthma in children or adults..

American Academy of Pain Medicine (AAPM)

Summary: Risk management is definitely on the minds of pain specialists who are worried that overly aggressive regulations will affect patient access to appropriate medications. ♦ Industry and the FDA still appear to be far apart on the design of a class-wide REMS for long-acting opioids. ♦ There was little discussion of the new abuse-resistant and abuse-deterrent opioids in development. ♦ The REMS for Meda Pharmaceuticals’ buccal fentanyl, Onsolis, has opinion leaders outraged, but most other doctors don’t find it onerous. ♦ So far, doctors have been underwhelmed with Johnson & Johnson’s Nucynta IR. ♦ King Pharmaceuticals’ Embeda is catching on, but slowly. ♦ Experts were speculating that Abbott Laboratories will resume efforts to get Vicodin CR approved. ♦ The data from Jazz Pharmaceuticals’ second Phase III trial of Xyrem in fibromyalgia looked very good.

Eye FDA Institutes Risk Management Program for Erythropoiesis-Stimulating Agents (ESAs) Given to Cancer Patients -- Quick Pulse

Summary: Starting no later than March 25, 2010, Amgen will begin enrolling healthcare providers and hospitals in a new Risk Evaluation and Management Strategy (REMS) for all ESAs – Amgen’s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and Johnson & Johnson’s Procrit (epoetin alfa manufactured by Amgen). In a teleconference with reporters, FDA officials insisted the new REMS is designed to help cancer patients make more informed decisions about the risk:benefit ratio of using ESAs, not to ban ESA use, but they also said the program is “designed to help ensure the appropriate administration of these drugs.” 

Eye Care Update

Summary: For optometrists, the economic downturn appears to have bottomed, but no real pickup is expected this year. ♦ Contact lens fittings are holding relatively steady, with both daily disposable lenses and silicone hydrogel lenses picking up a little. ♦ Referrals for refractive surgery are down 16% vs. January 2009, and the outlook is for a flat 2010. ♦ When generic versions of Pfizer.s Xalatan become available in October 2011, it is likely to expand the patients treated for glaucoma, expand the number of patients on a prostaglandin, but cannibalize other branded prostaglandins in terms of both new and existing patients. Optometrists are already seeing fewer Xalatan samples and fewer visits by Pfizer sales reps. ♦ Use of Allergan.s Restasis for dry eye is increasing, but cost remains the main limiting factor. ♦ Use of Allergan.s Latisse to lengthen eyelashes is catching on. Most patients who try it, like it, and keep using it, so doctors are increasingly writing prescriptions for it.

American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI)

Summary: Colorectal cancer: Use of Amgen’s Vectibix in CRC is increasing slowly due to new data and lower pricing. Oncologists are anxious for a biomarker to predict response to Avastin in CRC. Some oncologists believe Genentech is impeding development of a predictive SNP, but Roche has a team working hard to find a biomarker. The N-0147 trial of adjuvant Lilly/ImClone’s Erbitux in CRC has been stopped due to lack of efficacy and safety, and first-line use of Erbitux is not catching on. ♦ Liver cancer: Negative data from Japan on Bayer/Onyx’s Nexavar in liver cancer is not worrying oncologists. ♦ Neuroendocrine tumors: The Phase III results of Pfizer’s Sutent were so positive that they are likely to be practice changing. ♦ Gastric cancer: The ToGA trial data on Roche/Genentech’s Herceptin in HER2+ gastric cancer have the potential to increase use of Herceptin by 35% in the U.S. and Japan together. ♦ Investigational agents: Oncologists are not optimistic about the outlook for AstraZeneca’s VEGF inhibitor Recentin (cediranib, AZD-2171) in CRC or Merck’s IGF-1R inhibitor MK-0646 in pancreatic cancer. ♦ Octapeptides: Diagnostic use is expected to go down in favor of CT/MR, but therapeutic use is holding steady.