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Practitioner PanelsBrand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management GSK updates label for Advair, Serevent, as requested by FDA GlaxoSmithKline Plc updated its product label for Advair Diskus (fluticasone propionate/salmeterol xinafoate) and Serevent Diskus (salmeterol xinafoate) with a strict new warning that advises physicians to limit their prescribing of the drugs to specific patient populations.The Food and Drug Administration requested the new safety labeling in October. According to the FDA, long-acting beta 2-agonists (LABAs) such as these can decrease the occurrence of asthma episodes. However, when the episodes do occur, these drugs can make them more severe. A recent study showed that salmeterol can increase the risk of death during a severe episode. The new label suggests that physicians evaluate whether a patient's asthma can be adequately controlled by using other controller drugs, such as inhaled corticosteroids, before prescribing a LABA. The label also recommends that physicians consider whether the severity of a patient's disease warrants initial treatment with an ICS and a LABA. Additionally, GSK will provide a medication guide for patients to have "easy-to-understand information on the safety and proper use of [the drugs]." According to an unidentified GSK executive cited in a Forbes report, at present, only 6 percent of Advair use is among patients who were not previously on medication for their asthma. The report also noted that when the new labeling is in place, physicians who prescribe Advair as an initial treatment for mild asthma cases will be prescribing the drug "off-label." Practitioner Panels Celgene's Revlimid granted priority review by FDA for multiple myeloma The Food and Drug Administration granted Celgene Corp.'s Revlimid (lenalidomide) priority review for the treatment of relapsed or refractory multiple myeloma. Revlimid is already approved to treat transfusion-dependent anemia resulting from low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. The supplemental New Drug Application for the multiple myeloma indication is seeking approval for the drug's use in combination with dexamethasone as a treatment for patients with multiple myeloma who have taken at least one previous treatment. The application is based on data from two Phase III trials, MM-009 and MM-010. Both trials involved patients with previously treated multiple myeloma and found that Revlimid plus dexamethasone significantly delayed time to disease progression as compared with placebo plus dexamethasone. While the sNDA is under review, Celgene's Expanded Access Program will make Revlimid available to qualified patients with relapsed or refractory multiple myeloma, Celgene said. Revlimid, which is distributed under a special restricted program due to its potential to cause birth defects or death to an unborn child, is being studied in several other oncology- and hematology-related conditions. Practitioner Panels Hospira's Endrate causes two deaths, investigation into third Hospira Inc.'s Endrate (edetate disodium), or Na2EDTA, is linked to the death of two children and possibly that of a woman aged 53 years, according to a report from the Centers for Disease Control and Prevention. Endrate, a chelating agent, is used to treat lead poisoning. Chelating agents are chemical compounds, injected or given orally, that bind to metals in the body and carry them through urine or feces. Some physicians use chelation therapy to treat autism, believing that mercury or other heavy metals produce the symptoms of the disorder. However, there is no medical evidence to support that claim, and the drug is not approved for that indication or for use in pediatric patients, CDC officials told The Wall Street Journal. 3M Pharmaceuticals' Calcium Disodium Versenate (edetate calcium disodium), or CaEDTA, is the only agent recommended for intravenous chelation therapy for children. Hospitals, however, usually stock multiple chelation agents. The deaths of the two children, aged 2 years and 5 years, were caused by sudden cardiac arrest resulting from hypocalcemia after Endrate was administered. An investigation into the death of the woman is currently being conducted to determine whether she received Na2EDTA or CaEDTA. The CDC report stated that in some cases, Na2EDTA is administered due to errors in "look-alike, sound-alike" substitutions. The Food and Drug Administration is performing a safety evaluation of Na2EDTA and reviewing the adverse event report system to determine whether other deaths relating to the use of chelating agents have occurred. Practitioner Panels FDA advisory committee to discuss sNDA for Cubist's injectable antibiotic The Anti-Infective Drugs Advisory Committee of the Food and Drug Administration is scheduled to meet Monday to discuss Cubist Pharmaceuticals Inc.'s supplemental New Drug Application for the injectable antibiotic Cubicin (daptomycin). The sNDA seeks approval for the drug to treat patients with Staphylococcus aureus infections, including patients with known or suspected endocarditis. In pre-meeting documents posted on the FDA's Web site, the agency said it would be asking the committee's advice on the following: the drug's performance in the overall population and in subgroups such as infective endocarditis, the implications of patients developing increasing minimum inhibitory concentration to Cubicin and how clinical trials in patients with endocarditis should be designed. The briefing documents noted that a study of Cubicin showed the drug's noninferiority to a comparator drug in the overall population with at least one blood culture testing positive for S. aureus, but the study population was heterogeneous, there were a small number of patients with endocarditis and, in overall failures, there was a higher proportion of relapsing or persisting bacteremia in Cubicin-treated patients. The documents also said some patients, most of whom had persistent or relapsing bacteremia, demonstrated increasing minimum inhibitory concentrations to Cubicin while receiving treatment. Furthermore, the agency said studies that enroll patients based only on a blood culture that tests positive for S. aureus, might not reach a "substantial clinical experience in infective endocarditis." According to Cubist, the documents posted on the agency's Web site are not the only ones that will be seen by the committee. "It is Cubist's understanding that an additional document from the FDA, with corrections and clarifications to the FDA briefing document, is being made available to the advisory committee and will be posted, although we do not know if this will happen prior to Monday's meeting," the firm said in a statement. Cubicin is currently indicated to treat complicated skin and skin structure infections caused by certain gram-positive microorganisms. Practitioner Panels Single dose of Novartis' Famvir improves healing time in patients with cold sores A single dose of Novartis Pharmaceuticals Corp.'s antiviral Famvir (famciclovir) given to patients with recurrent herpes labialis (cold sores) within the first hour of symptoms significantly improves healing time, a recent study found. In the double-blind trial, patients were randomized to receive a single dose of Famvir (1,500 mg, n=152), single-day dosing of Famvir (750 mg twice, n=157) or placebo (n=168). When taken at the first symptom of an outbreak and before lesions appeared, Famvir was found to significantly reduce the time to healing of primary vesicular lesions. Among patients who received the single dose of Famvir, the median time to healing was 4.4 days; among those who received Famvir twice in the same day, the median time to healing was four days; for placebo, it was 6.2 days. No significant difference was observed between the treatment groups regarding the proportion of patients with aborted lesions, Novartis said. The study also found that, compared with placebo, treatment with a single dose of Famvir significantly reduced the time to return to normal skin and the time to resolution of pain and tenderness in patients with lesions. "This is the first study of its kind to show the benefit of administering a full course of antiviral therapy in a single dose when the virus is most active," Novartis said. Last fall, Novartis filed a supplemental New Drug Application seeking indications for single-dose Famvir to treat recurrent herpes labialis in immunocompetent patients and single-day Famvir to treat immunocompetent patients with recurrent genital herpes. These data were presented at the annual meeting of the American Academy of Dermatology in San Francisco. Practitioner Panels Analyses show Roche's Roferon-A not cost effective, quality of life not improved compared with placebo in patients with melanoma in United Kingdom Roche's Roferon-A (interferon alpha-2a, recombinant) is unlikely to be cost effective and does not significantly improve quality of life in patients using the drug to treat melanoma in the United Kingdom, according to analyses of data from the AIM-High trial. The trial included 674 patients with thick primary cutaneous melanoma who were randomized to receive placebo or 3 megaunits of Roferon-A three times per week for two years or until recurrence. Health-related quality of life was measured by the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30, while costs were estimated at 2003/2004 price levels. After adjusting for baseline quality of life and overall survival status, data showed that patients who received placebo experienced significantly better average follow-up scores on the EORTC QLQ-C30's seven symptom dimensions relative to patients who received Roferon-A. Additionally, with the same adjustments, patients in the placebo group had significantly better mean follow-up quality of life as measured by the five function dimensions (physical, role, emotional, cognitive and social functioning) of the EORTC QLQ-C30 than did Roferon-A-treated patients. Moreover, economic data from 111 of the patients concluded that costs were higher for the Roferon-A-treated patients during the first two years, but were slightly lower thereafter. Costs were approximately $6,300 greater in the Roferon-A group, which was nearly entirely the result of the drug's cost, but this was not statistically significant. Roferon-A did generate an extra 27 days of full health as compared with the placebo group, but this difference also was not statistically significant. So, the drug produced an incremental cost per quality-adjusted life year of approximately $72,540 at five years, which the investigators said was a statistically uncertain result. "Using a funding threshold of [approximately $52,515] per QALY, which is at the higher end of a range used within the United Kingdom, these results show that low-dose extended duration [Roferon-A] therapy is unlikely to be considered cost effective," the study authors concluded. This analysis was published in the Feb. 27 issue of the British Journal of Cancer. Practitioner Panels Practitioner Panels The Food and Drug Administration The Food and Drug Administration issued recommendations to help drug manufacturers develop seasonal and pandemic influenza vaccines. Consistent with the goals of the agency's Critical Path Initiative, the recommendations are intended to help speed up the development and availability of safe and effective flu vaccines. The guidelines include information about submitting supplemental data for already-approved seasonal vaccines that are to be used as pandemic vaccines. They also describe "defined pathways for both traditional and accelerated approval requests" for new vaccines. Practitioner Panels Practitioner Panels The Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services provided a draft memo to health insurers and employers outlining preliminary information about the Medicare Part D drug plans for 2007. The document contains guidance on how the agency will review aspects of the Medicare drug plans provided by insurers in 2007, including review of formularies, drug categories and classes, tier placement for drugs, utilization management practices and long-term accessibility. Although insurers were permitted to sponsor up to three plans per region in 2006, CMS is considering limiting insurers to one "basic" plan and one "enhanced" drug plan in each region as a way to simplify the choices for beneficiaries, The Wall Street Journal reported. The CMS is requesting insurers to respond to the draft guidance by March 6. Practitioner Panels Practitioner Panels Takeda Pharmaceutical Co. Ltd. Takeda Pharmaceutical Co. Ltd. selected a cardiovascular drug target from Lexicon Genetics Inc. under an alliance the firms entered into in July 2004. Takeda made a $5 million milestone payment to Lexicon to begin research on LG474. The firms' agreement involves the development of new drugs directed against hypertension targets in Lexicon's Genome5000 program. Takeda will have exclusive access to the drug target for the three-year term of the agreement and will be responsible for all development and commercialization of any resulting drugs. Should a product launch, Takeda will pay royalties and additional milestones. Practitioner Panels Practitioner Panels Advanced Magnetics Inc. Advanced Magnetics Inc. designed a Phase III development program for ferumoxytol, an investigational intravenous iron replacement therapeutic in patients with chronic kidney disease, following communication with the Food and Drug Administration. Advanced Magnetics established the primary efficacy analysis for the three Phase III studies, which will compare the mean change in hemoglobin from baseline between ferumoxytol and oral iron. Advanced Magnetics shares closed at $27.20, up $1.81, or 7.1 percent, in heavy trading on the American Stock Exchange. Practitioner Panels
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