Formulary Watch |

FDA launches new organizational performance management system to advance transparency

FDA has launched a performance management system designed to advance transparency, public participation, and collaboration in the work of government.

Data compare dabigatran etexilate to dose-adjusted warfarin across RE-LY trial centers

Boehringer Ingelheim announced Aug. 29 that results from a pre-specified, retrospective, unblinded subanalysis of the RE-LY trial ? the largest atrial fibrillation outcomes trial ever conducted ? were published in The Lancet.

Genetic substudy shows fewer major cardiovascular events with ticagrelor, regardless of relevant genetic variability in ACS patients

A new genetic substudy of PLATO (A Study of PLATelet Inhibition and Patient Outcomes) showed that the effects on a combined primary end point of cardiovascular death, myocardial infarction, or stroke seen in patients with acute coronary syndromes (ACS) who received the investigational oral antiplatelet treatment, ticagrelor (Brilinta, AstraZeneca), were maintained, whether or not they had the genetic variability that has been previously shown to affect a patient?s response to clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi Pharmaceuticals).

AMCP voices support for a national inventory of comparative effectiveness research

The Academy of Managed Care Pharmacy (AMCP) has responded to a request from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) in the Department of Health and Human Services (HHS). In this request, ASPE indicates that it is developing a national inventory of comparative effectiveness research (CER) and CER-related information driven by the American Recovery and Reinvestment Act, signed into law by President Obama in 2009.

AMCP urges HHS not to consider formulary changes when determining "grandfathered" status for health plans under reform law

The Academy of Managed Care Pharmacy (AMCP) has provided comments in response to a June 17 Federal Register notice on the Interim Final Rules for Group Health Plans and Health Insurance Coverage Relating to Status as a Grandfathered Health Plan Under the Patient Protection and Affordable Care Act, also known as The Grandfathering Rule.

Suicide concerns prompt early termination of rimonabant trial

A study evaluating the cardiovascular outcomes related to rimonabant was discontinued because of concerns regarding the risk of suicide associated with the weight-loss drug, according to a report in the Aug. 14 issue of The Lancet, as reported by HealthDay News.

New classification system may allow for earlier identification, treatment of RA

A revised system of classification for rheumatoid arthritis (RA) may allow for earlier identification of the disease, earlier treatment, and ultimately better patient outcomes. The new system has been published in the September issues of the Annals of the Rheumatic Diseases and Arthritis & Rheumatism, as reported by HealthDay News.

Research shows decline in hospitalizations for peptic ulcer disease, H. pylori infection

Hospitalization rates for peptic ulcer disease and Helicobacter pylori infection have decreased substantially since 1998, according to an analysis in the September issue of Emerging Infectious Diseases, as reported by HealthDay News.

Bisphosphonate exposure not linked to esophageal cancer

There appears to be no association between the use of oral bisphosphonates and the risk of esophageal or gastric cancer, according to research published in the Aug. 11 issue of the Journal of the American Medical Association, as reported by HealthDay News.

Novo Nordisk gets approval for 8-mg vial of NovoSeven RT

FDA has approved NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8-mg vial size, making the hemophilia A or B with inhibitors treatment available in 1-, 2-, 5-, and 8-mg vials, Novo Nordisk announced on Aug. 10. The 8-mg vial allows a rapid initiation and administration of the medication for those patients who need a larger dose.

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

FDA approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease, according to Genentech Inc. on Aug. 10.

Hospital-acquired MRSA infections decline between 2005 and 2008

Infections with the deadly methicillin-resistant Staphylococcus aureus (MRSA) bacteria that begin in hospitals and other healthcare settings have declined 28% over a 4-year period, according to a new Centers for Disease Control and Prevention (CDC) study of about 15 million people. The study was published in the Aug. 11 issue of the Journal of the American Medical Association, as reported by HealthDay News.

Newer AEDs linked to self-harm, suicidal behavior

Patients taking newer antiepileptic drugs (AEDs) that are associated with a high risk of depression may have an elevated risk of self-harm or suicidal behavior, but other groups of AEDs do not appear to carry the same risk, according to research published in the July 27 issue of Neurology, as reported in HealthDay News.

OAD agents effective in reducing hemoglobin levels up to 1.5%

Oral antidiabetic (OAD) agents generally result in a maximum 1.5% drop in hemoglobin (Hb) A1C levels, with sulfonylureas and thiazolidinediones having a slightly more beneficial effect than other classes of oral agents, according to research published in the August issue of Diabetes Care, as reported by HealthDay News.

Naltrexone, bupropion combination helps individuals lose excess weight

Investigational combination treatment with sustained- release (SR) naltrexone and bupropion (Contrave, Orexigen Therapeutics)?plus lifestyle modification, appears effective in helping people lose 5% or more of their excess body weight, according to research published online July 30 in The Lancet, as reported by HealthDay News.

Lorcaserin linked to weight loss, maintenance

The use of lorcaserin, along with behavioral modification, is associated with weight loss and subsequent weight maintenance compared with placebo, according to a study published in the July 15 issue of the New England Journal of Medicine, HealthDay News reported.

MPV4 vaccine not linked to Henoch-Schönlein purpura

Meningococcal polysaccharide vaccine (MPV4) does not appear to be associated with post-vaccination Henoch-Schönlein purpura (HSP) in 16- to 20-year-olds, according to research published online July 12 in Pediatrics, HealthDay News reported.

Bias risk higher in industry-funded pediatric studies

A high proportion of pediatric, randomized controlled trials (RCTs) have a high risk for bias, particularly those that are industry-funded or involve assessment of behavioral/educational interventions, but trial registration is linked to less risk of bias, according to research published online July 12 in Pediatrics, HealthDay News reported.

Triple antihypertensive combination therapy may be better than dual therapy in diabetic patients with hypertension

Investigational triple antihypertensive combination therapy lowers blood pressure more effectively than dual therapy in diabetic patients with hypertension, according to the results of a subgroup analysis of the TRINITY study.

FDA approves first-time generic Lovenox

Sandoz, the generics division of Novartis, is the first company to receive US approval to market a generic version of the leading hospital-based medication, Lovenox (enoxaparin sodium), the ?gold standard? in anti-thrombotic treatment. No sooner did Sandoz begin shipments of the generic version, Sanofi-Aventis, manufacturer of Lovenox, filed a lawsuit to prevent the approval of the generic. Last year, Lovenox recorded $4.57 billion in sales for Sanofi-Aventis, according to IMS Health. Both the new generic and Lovenox are low-molecular-weight heparin anticoagulants that help prevent deep vein thrombosis.

New tyrosine kinase inhibitors may represent new standard in chronic-phase CML

Major molecular responses are more common with the next generation of tyrosine kinase inhibitors as first-line options compared with imatinib for the treatment of newly diagnosed patients with chronic myelogenous leukemia (CML). Two separate studies confirmed superior response rates with dasatinib and nilotonib versus the current first-line standard imatinib.

Continuous daily sunitinib enhances response rates in advanced pancreatic tumors

Continuous daily sunitinib significantly improves overall survival and progression-free survival (PFS) in patients with advanced pancreatic neuroendocrine tumors, according to data from a phase 3 study.

Lorcaserin linked to weight loss, maintenance

The use of lorcaserin, along with behavioral modification, is associated with weight loss and subsequent weight maintenance compared with placebo, according to a study published in the July 15 issue of the New England Journal of Medicine, HealthDay News reported.

MPV4 vaccine not linked to Henoch-Schönlein purpura

Meningococcal polysaccharide vaccine (MPV4) does not appear to be associated with post-vaccination Henoch-Schönlein purpura (HSP) in 16- to 20-year-olds, according to research published online July 12 in Pediatrics, HealthDay News reported.

Bias risk higher in industry-funded pediatric studies

A high proportion of pediatric, randomized controlled trials (RCTs) have a high risk for bias, particularly those that are industry-funded or involve assessment of behavioral/educational interventions, but trial registration is linked to less risk of bias, according to research published online July 12 in Pediatric, HealthDay News reported.

Formulary Digital Edition, August 2010

Disease-modifying therapy in adult relapsing-remitting multiple sclerosis; Focus on fingolimod; Agents in late-stage development for the management of weight

Drug Watch: Weight management agents (PDF) (August 2010)

Weight management agents in late-stage development.

FDA Actions in Brief August 2010 (Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa)

Recent FDA Approvals (through July 2010) related to Tribenzor, Daiichi Sankyo, Aricept, Eisai and Pfizer, Daytrana, Glassia, Zuplenz, Infergen, Cuvposa

Fingolimod: A potential first-in-class oral therapy for the treatment of relapsing-remitting multiple sclerosis

Fingolimod is an investigational drug being studied for the treatment of relapsing-remitting multiple sclerosis (RRMS) and may represent a first-in-class sphingosine 1-phosphate receptor modulator as well as the first oral therapy for the treatment of RRMS.

Disease-modifying therapy in adult relapsing-remitting multiple sclerosis

Multiple sclerosis (MS) is a significant cause of disability among young adults, more commonly women, and usually strikes patients in the prime of their lives. Despite recent therapeutic advancements, MS remains an incurable, chronic illness. Clinical evidence supports the role of disease-modifying therapy early in the disease course to reduce the number of acute attacks, delay disease progression, maintain quality of life, and prevent disability.