A phase 2 study published in the New England Journal of Medicine reported that alemtuzumab was more effective than interferon beta-1a in treating early, relapsing-remitting multiple sclerosis (MS), but the agent was also associated with higher rates of autoimmunity, including cases of immune thrombocytopenic purpura (ITP).
To effectively gauge the potential clinical and economic impact of drug and biologic therapies that are pending FDA approval, the monitoring of pharmaceutical pipelines has become an essential function of pharmacy benefit management (PBM) companies and managed care organizations (MCOs); one source of pharmaceutical pipeline information is subscription-based pharmaceutical pipeline databases. Examples of some of these databases, along with the types of information provided and advantages and disadvantages of such products, are presented.
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 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.
Recent FDA action (through November 2008) related to aztreonam lysine, fentanyl buccal, tocilizumab, everolimus, ENB-0040, and artemether/lumefantrine
Generic drugs approved by FDA (through November 2008) including galantamine extended-release capsules and carbidopa/levodopa orally disintegrating tablets
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
Agents in late-stage development for the treatment of insomnia and restless legs syndrome (RLS)
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
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.
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 announced that the agency has posted on its website a report listing drugs that are being investigated for potential safety concerns.
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.
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.
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)
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.
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).
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.
Recent FDA action (through October 2008) related to vernakalant, doripenem, custirsen, droxidopa, amrubicin, dronedarone, and imatinib.
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.
Recent FDA approvals and indications (through October 2008) related to Cancidas, Aloxi, and Vidaza.
New biologic: Romiplostim (Nplate), a thrombopoietin mimetic peptibody, was approved on August 22, 2008, for the treatment of chronic ITP.
