Formulary Watch |

Ticagrelor reduces death rate in patients with adult coronary syndrome

Treatment with ticagrelor compared with clopidogrel in patients with acute coronary syndromes significantly reduced the death rate from vascular causes, myocardial infarction (MI), or stroke, according to the Study of Platelet Inhibition and Patient Outcomes (PLATO), a multicenter, randomized, double-blind trial.

FDA continues to closely monitor the cardiovascular safety of rosiglitazone

On February 22, 2010, FDA released a safety alert reminding healthcare professionals of the agency¹s ongoing concerns regarding the cardiovascular safety of rosiglitazone (Avandia, GlaxoSmithKline).

Drug Watch: Agents in late-stage development for the treatment of diabetes mellitus (PDF) (March 2010)

Agents in late-stage development for the treatment of diabetes mellitus.

Tocilizumab (Actemra): An interleukin-6 receptor inhibitor for the treatment of rheumatoid arthritis

New molecular entity: Tocilizumab (Actemra) was approved in January 2010, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

FDA actions in brief, March 2010 (Iprivask, VPRIV, Mirapex ER, Cayston, Menveo, Lamictal XR, Rituxan, Oleptro, Xiaflex, Norvir, Benicar, Crestor)

Recent FDA approvals (through March 2010) related to Iprivask, VPRIV, Mirapex ER, Cayston, Menveo, Lamictal XR, Rituxan, Oleptro, Xiaflex, Norvir, Benicar, Crestor.

A review of the prevention and treatment of venous thromboembolism

Venous thromboembolism (VTE) is a debilitating and potentially fatal condition, often seen in the aging population. VTE results from clot formation in the venous circulation and presents as either deep-vein thrombosis or pulmonary embolism. A population-based study estimated that at least 201,000 new cases of VTE occur in the United States annually.

Etravirine: A unique non-nucleoside reverse transcriptase inhibitor for the treatment of HIV-1

Etravirine is an HIV-1 specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) that was FDA approved for treatment-experienced adult patients with HIV-1 strains resistant to an NNRTI and other antiretroviral agents. In phase 3 trials of etravirine versus placebo, both in combination with darunavir/ritonavir, a background of nucleoside/nucleotide reverse transcriptase inhibitors with or without enfuvirtide demonstrated potent antiviral activity that was sustained through 48 weeks.

Gout: Overview and newer therapeutic developments

The main objectives of gout therapy are to treat the acute attack, provide prophylaxis to prevent flares, and prevent complications associated with the deposition of urate crystals in tissues. Obesity, alcohol intake, and certain foods and medications can contribute to hyperuricemia and should be identified. Pharmacologic management remains the mainstay of treatment for chronic gout and acute attacks.

Liraglutide (Victoza): A GLP-1 analog approved for the treatment of type 2 diabetes

New molecular entity: Liraglutide (Victoza) was approved January 25, 2010 to improve blood sugar control in adults with type 2 diabetes mellitus.

FDA Pipeline preview, March 2010 (CPI-300, Ondansetron, Intravenous acetaminophen, Gabapentin enacarbil, Rifaximin, ENMD-2076, Ap301, CM-AT, Fingolimod, Nilotinib)

Recent FDA action (through March 2010) related to CPI-300, Ondansetron, Intravenous acetaminophen, Gabapentin enacarbil, Rifaximin, ENMD-2076, Ap301, CM-AT, Fingolimod, Nilotinib.

FDA imposes new safety requirements to curb use of LABAs in asthma patients

On February 18, 2010, FDA recommended drastic changes in the way long-acting beta2-adrenergic agonists are used in the treatment of asthma in order to limit their utilization.

Formulary Digital Edition March 2010

Gout: Overview and newer therapeutic developments; Focus on etravirine; Agents in late-stage development for the treatment of diabetes mellitus

2010 Rate Card

2010 Media Kit

Rotavirus vaccination may lessen occurrence of gastroenteritis in small children

In the first year of a child's life, immunization with a rotavirus vaccine (Rotarix, Glaxo Smith Kline) may markedly lower incidence of severe virus gastroenteritis.

Drugs for orphan diseases seeing more FDA approvals

In the past decade, federal regulatory agencies have signed off on more new product approvals for treatment of so-called neglected diseases.

Exenatide LAR: A sustained-release formulation of exenatide for the treatment of type 2 diabetes

Currently, exenatide is the only FDA-approved GLP-1 receptor agonist and its use is limited by the need for twice-daily injections. A long-acting release formulation of exenatide is being evaluated in clinical trials to assess effects on glucose control and patient quality of life.

Approaching the ideal selective estrogen receptor modulator for prevention and treatment of postmenopausal osteoporosis

Postmenopausal osteoporosis is a worldwide health concern associated with significant complications including fracture, disability, and mortality. The economic burden of this disease is substantial and is expected to increase significantly as the population ages. It is becoming increasingly important to identify patients who will benefit from available and emerging therapies for the prevention and/or treatment of osteoporosis.

Formulary Digital Edition February 2010

Approaching the ideal selective estrogen receptor modulator for prevention and treatment of postmenopausal osteoporosis; Exenatide LAR: A sustained-release formulation of exenatide for the treatment of type 2 diabetes; and Agents in late-stage development for renal diseases

Drug Watch: Agents in late-stage development for renal disease (February 2010) (PDF)

Agents in late-stage development for renal disease

FDA Pipeline preview, February 2010 (Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126)

Recent FDA action (through February 2010) related to Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126

FDA Commissioner Hamburg builds agency's capabilities for bringing new therapies to patients

FDA actions in brief, February 2010 (Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose)

Recent FDA approvals (through February 2010) related to Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose

FDA finds no increased cardiovascular risk in patients using tiotropium

After completing a review of available tiotropium bromide inhalation powder (Spiriva HandiHaler, Pfizer) data, FDA released an updated communication, stating that in the regulatory body's opinion, available data does not support an association between the use of tiotropium, a commonly prescribed daily treatment for chronic obstructive pulmonary disease, and an increased risk of stroke, heart attack, or cardiovascular death.

Disease-modifying antirheumatic drugs prove most cost-effective in very early RA

Therapeutic strategies involving early conventional disease-modifying antirheumatic drugs or early biologics are preferred in treating very early rheumatoid arthritis, but the additional costs of early biologics may not be justified for all patients, according to a recent study reported in the Annals of Internal Medicine.

Vigabatrin (Sabril): An antiepileptic drug approved for the treatment of refractory complex partial seizures in adults and spasms in infants

New molecular entity: Vigabatrin (Sabril) was approved as an adjunctive treatment of refractory complex partial seizures in adults who have responded inadequately to several alternative treatments; and as monotherapy for pediatric patients with infantile spasms.

First-time generic approvals, February 2010

Generic drugs approved by FDA (through February 2010): Donepezil hydrochloride orally disintegrating tablets, Ibutilide fumarate injection, Risperidone orally disintegrating tablets in 0.5-mg, 2-mg, 3-mg, and 4-mg strengths

Higher dosage of losartan needed for maximal benefit in patients with CHF and left ventricular dysfunction

A dosage of losartan of 150 mg/day is superior to 50 mg/day for the treatment of patients with congestive heart failure (CHF).

Low-dose drug combination shows better outcomes for myeloma patients

Lenalidomide plus high-dose dexamethasone compared with lenalidomide plus low-dose dexamethasone did not result in superior time to progression, progression-free survival, or overall survival in patients with newly diagnosed myeloma, according to a recent trial.

ER niacin bests ezetimibe on measure of atherosclerosis

Extended-release niacin proved better than ezetimibe in favorably changing carotid intima-media thickness, a measure of atherosclerosis, in high-risk patients who were already receiving a statin.