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Focus on 2008: A year of novel pharmacologic agents in review

This article reviews the 10 newly improved or investigational agents evaluated in this year's "Focus on" column and includes an update on the regulatory status of each drug.

Prasugrel: A novel thienopyridine prodrug for the treatment of acute coronary syndrome

Prasugrel is a thienopyridine prodrug under FDA review for the treatment of acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI). Clinical trials have demonstrated statistically significant inhibition of platelet aggregation with prasugrel relative to placebo and clopidogrel; however, this improved efficacy outcome entails a significantly increased rate of bleeding.

FDA Pipeline preview, November 2008 (aztreonam lysine, fentanyl buccal, tocilizumab, everolimus, ENB-0040, artemether/lumefantrine)

Recent FDA action (through November 2008) related to aztreonam lysine, fentanyl buccal, tocilizumab, everolimus, ENB-0040, and artemether/lumefantrine

First-time generic drug approvals, November 2008

Generic drugs approved by FDA (through November 2008) including galantamine extended-release capsules and carbidopa/levodopa orally disintegrating tablets

FDA actions in brief, November 2008 (Gardasil, Gamunex, Alimta, Nasacort AQ, ProAir HFA, Keppra XR, Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System)

Recent FDA approvals (through November 2008) related to Gardasil, Gamunex, Alimta, Nasacort AQ, ProAir HFA, Keppra XR, and Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System

Granisetron transdermal system (Sancuso): Antinauseant/antiemetic agent approved for the prevention of chemotherapy-induced nausea and vomiting

FDA drug approvals

Drug Watch: Agents in late-stage development for the treatment of sleep disorders (November 2008) (PDF)

Agents in late-stage development for the treatment of insomnia and restless legs syndrome (RLS)

Formulary Digital Edition November 2008

Year-end "Focus on": News and updates on the novel pharmacologic agents reviewed over the past 12 months; Focus on prasugrel; Pharmaceutical pipeline database products

Development of taranabant for obesity discontinued

Merck has announced that they are discontinuing development of taranabant, an investigational selective blocker of the cannabinoid-1 (CB-1) receptor that was being studied for the treatment of obesity.

Tibolone reduces fracture and breast CA risk, increases stroke risk

The Long-Term Intervention on Fractures with Tibolone (LIFT) study demonstrated a reduced risk of vertebral fracture, breast cancer, and possibly colon cancer but a significantly increased risk of stroke in older postmenopausal women treated with tibolone versus those treated with placebo.

FDA posts quarterly drug safety report

FDA announced that the agency has posted on its website a report listing drugs that are being investigated for potential safety concerns.

Case of PML reported in efalizumab-treated patient

Genentech informed healthcare professionals that a 70-year-old patient who has been treated with efalizumab (Raptiva) for chronic psoriasis for >4 years has developed progressive multifocal leukoencephalopathy (PML), a rare, progressive disease of the central nervous system that is usually fatal.

Tiotropium improves long-term lung function in COPD

In the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial, tiotropium therapy for patients with chronic obstructive pulmonary disease (COPD) was associated with long-term improvements in lung function, quality of life, and COPD exacerbations. The therapy did not, however, significantly reduce the rate of decline in forced expiratory volume in 1 second (FEV1) compared with placebo.

Formulary Digital Edition October 2008

Rational approaches to the treatment of mixed dyslipidemia; Focus on eltrombopag; Drug Watch: Agents in late-stage development for the treatment of hepatitis B and C virus infections

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Drug Watch: Agents in late-stage development for the treatment of hepatitis B and C virus infections (October 2008) (PDF)

Drug Watch: Agents in late-stage development for the treatment of hepatitis B and C virus infections (October 2008)

Congress to consider changes to Medicare Part D drug plans

Even though the Medicare prescription drug benefit has provided access to medications at less-than-anticipated cost to the government-and lower out-of-pocket spending for seniors-many Democrats and consumer advocates want to overhaul the program. Critics contend that the federal government can negotiate prices with pharmaceutical companies that are lower than those obtained by private insurers operating prescription drug plans (PDPs), and some reformers charge that the program is too complex and confusing for elderly beneficiaries, pointing particularly to the infamous "donut hole" that is affecting more Medicare patients than anticipated.

ARBs demonstrate no beneficial effect on mortality in patients with heart failure

A systematic search of the literature published in the International Journal of Clinical Practice demonstrated that angiotensin receptor blockers (ARBs) used as monotherapy or in combination with angiotensin-converting enzyme (ACE) inhibitors are not associated with a beneficial effect on mortality in patients with heart failure (HF).

Labeling updates and warnings through October 2008 for adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), and rituximab (Rituxan)

Labeling updates and warnings through October 2008 for adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), and rituximab (Rituxan).

Ipratropium associated with increased risk of death in patients with COPD

A nested case-control analysis published in the Annals of Internal Medicine demonstrated an increased risk of all-cause and cardiovascular mortality among patients with recently diagnosed chronic obstructive pulmonary disease (COPD) treated with ipratropium.

FDA Pipeline preview, October 2008 (vernakalant, doripenem, custirsen, droxidopa, amrubicin, dronedarone, imatinib)

Recent FDA action (through October 2008) related to vernakalant, doripenem, custirsen, droxidopa, amrubicin, dronedarone, and imatinib.

Eltrombopag: A TPO receptor agonist for the treatment of chronic idiopathic thrombocytopenic purpura

Eltrombopag is a TPO receptor agonist that is currently pending FDA approval for the treatment of ITP. This agent has been granted orphan drug and priority review status. In May 2008, the Oncology Drugs Advisory Committee unanimously agreed that eltrombopag demonstrates a favorable risk:benefit profile for the short-term treatment of chronic ITP.

FDA actions in brief, October 2008 (Cancidas, Aloxi, Vidaza)

Recent FDA approvals and indications (through October 2008) related to Cancidas, Aloxi, and Vidaza.

Romiplostim (Nplate): Thrombopoietin mimetic peptibody approved for the treatment of chronic ITP

New biologic: Romiplostim (Nplate), a thrombopoietin mimetic peptibody, was approved on August 22, 2008, for the treatment of chronic ITP.

Tetrabenazine (Xenazine): Monoamine depleter approved for the treatment of chorea associated with Huntington's disease

New molecular entity: Tetrabenazine (Xenazine), a monoamine depleter, was approved on August 15, 2008, for the treatment of chorea associated with Huntington's disease.

Rational approaches to the treatment of mixed dyslipidemia

This article reviews the role of individual therapeutic agents and combination therapies that can be used for the treatment of mixed dyslipidemia.

Comparative effectiveness research legislation likely to raise drug pricing issues

The Comparative Effectiveness Research Act of 2008 would establish the Health Care Comparative Effectiveness Research Institute as a private, nonprofit, nongovernmental entity that would contract with government agencies and private research organizations to conduct systematic reviews, observational studies, and randomized controlled clinical trials to obtain evidence regarding the clinical effectiveness of therapies and treatments.

Primary androgen deprivation therapy does not prolong survival in most patients with prostate cancer

Primary androgen deprivation therapy (PADT), the second most common treatment for localized prostate cancer following prostatectomy, is no more effective than conservative medical management for prolonging survival in most older patients with prostate cancer.

Labeling updates and warnings through September 2008

Labeling updates and warnings through September 2008 for intramuscular naltrexone (Vivitrol) and for simvastatin (Zocor; generic simvastatin), ezetimibe/simvastatin (Vytorin), and niacin extended-release/simvastatin (Simcor) when used concurrently with amiodarone (Cordarone; Pacerone; generic amiodarone)

Rofecoxib, valdecoxib associated with increased risk of stroke

A retrospective cohort study published in the journal Stroke demonstrated an increased risk of stroke among users of rofecoxib and valdecoxib but not among users of other nonsteroidal anti-inflammatory drugs (NSAIDs).