Drug Pipeline

Prompted by the 2009 H1N1 influenza outbreak, FDA has announced plans to create a mobile app that will help it gather information and send out alerts about adverse reactions to experimental medications prescribed during public health crises.

In December, FDA announced changes to Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs romiplostim (Nplate) and eltrombopag (Promacta).

Last month, economists in the Department of Health and Human Services (HHS) reported a big slow-down in healthcare spending for 2010. Outlays rose only 3.9% to $2.6 trillion, largely because the recession and unemployment reduced healthcare coverage and prompted people to skip doctor visits. Spending on prescription drugs increased at a record low 1.2% to $259.1 billion, as utilization stagnated, more generics replaced old blockbusters, and fewer new drugs came on the market.

An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.

An estimated 1.2 million Americans are discharged from a hospital with a diagnosis of acute coronary syndrome (ACS) each year. Now, a new randomized controlled trial dubbed "ATLAS ACS 2" (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), is suggesting rivaroxaban may reduce the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, but at a cost of increased major bleeding.

New molecular entity: Aflibercept once-monthly intravitreal injection is FDA approved to treat patients with wet (neovascular) age-related macular degeneration.

In patients with major depressive disorder (MDD) and general medical conditions, the use of antidepressants was safe and effective compared to patients without such conditions. Combination therapy was no different than monotherapy, regardless of the number of comorbidities present, according to the recent findings of a new randomized, single-blind, placebo-controlled trial published in The Annals of Family Medicine.

Vaccines are one of the greatest achievements of biomedical science and public health. Proper vaccination plays a critical role in the reduction of vaccine-preventable disease and related morbidity and mortality.

Respondents to a Formulary readers' poll would reserve the use of newly approved rivaroxaban (Xarelto, Janssen) for the management of chronic atrial fibrillation (AF) to those patients who have contraindications to warfarin, had unmanageable side effects to warfarin, or in whom warfarin was ineffective.

New indication: FDA approved Zolpidem tartrate sublingual tablets or the treatment of insomnia characterized by middle-of-the-night (MOTN) wakening followed by difficulty returning to sleep.

Orally inhaled dihydroergotamine (DHE) is a newly developed formulation of DHE for the treatment of acute migraine attack and is undergoing FDA review.

Hospital-acquired Clostridium difficile significantly prolongs the duration of a patient's stay in the hospital by at least 6 days, according to the findings of a study published online December 5, for the Canadian Medical Association Journal.

Methotrexate alone, with step up to other therapies only if a response is not achieved, is a reasonable starting strategy for treating "poor prognosis" rheumatoid arthritis (RA), said James O'Dell, MD, at the annual scientific meeting of the American College of Rheumatology, Chicago.

Romiplostim (Nplate, Amgen), a synthetic protein that binds to and stimulates the thrombopoietin receptor, induced a rapid platelet response in most adult patients with immune thrombocytopenia (ITP) who had low platelet counts or bleeding symptoms, regardless of splenectomy status.

Recent FDA action (through January 2012) related to dapagliflozin, progesterone vaginal gel 8%, ACH-1625 protease inhibitor, CPP-115 GABA aminotransferase inhibitor, AC607, NBI-98854 VMAT2 inhibitor, AIC246 inhibitor, CBP501, Porfimer sodium, inhaled nitric oxide, carbamazepine extended-release capsules, levetiracetam extended-release tablets

In mid-December, FDA reported that dronedarone (Multaq) increased the risk of serious cardiovascular events, including death, when used in patients with permanent atrial fibrillation (AF), according to its safety drug communication.

FDA approved ingenol mebutate (Picato, LEO Pharma) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK). It is the first topical AK therapy that can be used for as few as 2 or 3 consecutive days.

FDA recently announced that a clinical trial evaluating the effects of doripenem (Doribax, Janssen) on the treatment of patients with ventilator-associated pneumonia was halted because of an increase in death rate and a poor clinical cure rate.

FDA and Seattle Genetics, which makes brentuximab vedotin (Adcetris), have updated the warning label on the company’s cancer drug after a second patient developed progressive multifocal leukoencephalopathy.

Aspirin prophylaxis in people without prior cardiovascular disease does not appear to reduce cardiovascular death or cancer mortality, according to the results of a meta-analysis published online January 9 in the Archives of Internal Medicine.

Older women who use statins may be at an increased risk for diabetes mellitus, according to the results of a study published online January 9, in the Archives of Internal Medicine.

Approximately 1 in 100 patients undergoing total or partial knee replacement surgery and 1 in 200 patients undergoing total or partial hip replacement surgery will experience a venous thromboembolism event, including deep vein thrombosis and pulmonary embolism, before being discharged from the hospital, according to a new study.

The Endocrine Society recently released new clinical practice guidelines recommending that all patients have their blood-glucose levels tested upon admission to the hospital, even if they haven’t been diagnosed with diabetes.

The results of a long-term follow-up of chlorthalidone stepped-care therapy for isolated systolic hypertension demonstrated that the treatment is associated with a longer life expectancy.

Individuals who are able to maintain or decrease their blood pressure (BP) to normal levels during middle age have the lowest lifetime risk for cardiovascular disease. In contrast, individuals who experience an increase in BP have higher lifetime risks, according to a study published in Circulation.