Drug Pipeline

New indication: Lubiprostone (Amitiza), a chloride channel activator, was approved on April 29, 2008, for the treatment of irritable bowel syndrome with constipation (IBS-C) in women aged at least 18 years.

New biologic: Certolizumab pegol (Cimzia), a tumor necrosis factor blocker, was approved on April 22, 2008, for the reduction of the signs and symptoms of Crohn's disease and the maintenance of clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Istradefylline, a highly selective adenosine A2A receptor antagonist, is a new agent being investigated for the adjunctive treatment of the motor signs and symptoms of idiopathic Parkinson disease.

Treatment options for osteoporosis include calcium, vitamin D, estrogen plus progesterone, calcitonin, and bisphosphonates.

Generic drugs approved by FDA (through May 2008) including amifostine for injection, clobetasol foam, granisetron oral solution, calcium acetate capsules, and irinotecan injection.

NME: Bendamustine (Treanda), an alkylating agent, was approved on March 20, 2008, for the treatment of chronic lymphocytic leukemia (CLL).

At a March 5, 2008, commission meeting, the Medicare Payment Advisory Commission (MedPAC) discussed the feasibility of requiring pharmaceutical companies and medical product manufacturers to report financial relationships and gifts to physicians on a national basis.

Approximately 1.7 million healthcare-associated infections (HAIs) occur in US hospitals each year. These HAIs, which include pneumonia, bloodstream infections (BSIs), and urinary tract infections (UTIs), account for approximately 99,000 deaths and $5 billion in additional healthcare costs.

Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.

The Food and Drug Administration Amendments Act (FDAAA) enacted in September 2007 requires new initiatives to expand information on the risks and benefits of prescription drugs. One goal established in FDAAA is the modernization of FDA’s system for detecting adverse drug events (ADEs); therefore, the current system is being reviewed so limitations and capabilities can be identified.

Data from EPITHET presented at the International Stroke Conference 2008 demonstrates that extending the standard 3-hour window for tPA could benefit patients who suffer a stroke and have a perfusion-diffusion mismatch.

Label updates and warnings through April 2008 related to epoetin alfa and darbepoetin alfa, darunavir, and tiotropium.

Study shows no significant differences in safety risks between off-label use of drug-eluting stents (DES) and off-label use of bare-metal stents (BMS) and a decreased risk of repeat PCI with use of off-label BMS.

How-to guide for creating drug monographs and drug class reviews for evidence-based formulary consideration.

Treatment of diabetes with DPP-IV inhibitors; sitagliptin, vildagliptin, alogliptin, and saxagliptin.

Generic drugs approved by FDA (through April 2008) including cefuroxime for oral suspension, pramipexole tablets, alendronate once-daily tablets, and alendronate once-weekly tablets.

New biologic: Rilonacept (Arcalyst), a regeneron Interleukin-1 blocker was recently approved for the treatment of cryopyrin-associated periodic syndromes (CAPS).

NME: Desvenlafaxine (Pristiq), a selective serotonin and norepinephrine reuptake inhibitor was recently approved for the treatment of major depressive disorder.

Adding bevacizumab to treatment with paclitaxel does not prolong overall survival among patients with metastatic breast cancer; however, the combination therapy is associated with a significant improvement in progression-free survival, according to the results of a trial published in the New England Journal of Medicine (NEJM).

This article discusses pharmacologic options for the treatment of Crohn's disease, including aminosalicylates, corticosteroids, immunosuppresant agents, and biologic agents.

Colesevelam (Welchol) was approved on January 18, 2008, as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.

Labeling changes and safety information regarding Botox, selected antiepileptic drugs, Chantix, and Ortho Evra (through March 2008)

Etravirine is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) that was approved January 18, 2008, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to NNRTIs and other antiretroviral agents.

The use of rosiglitazone to treat type 2 diabetes in older patients has been associated with an increased risk of cardiovascular events.

In 2 studies, lenalidomide plus dexamethasone has been demonstrated to be an effective therapy for relapsed and/or refractory multiple myeloma.

Report by FDA's Science Board cites a need for updates to the agency's information infrastructure and research programs to avoid significant problems.

Ceftobiprole is the first anti-MRSA cephalosporin antibiotic to be sumbitted to FDA for approval. If approved, the drug will likely be considered a second-line antibiotic for the treatment of cSSSIs.

This article provides information about pharmacologic and nonpharmacologic treatments that are used to help people stop smoking, including the use of varenicline.

FDA-related information through February 2008 on Fluvoxamine extended-release capsules, dalbavancin, bazedoxifene, HPV vaccine (Cervarix), valrubicin, motexafin gadolinium, COL-003, CDX-110, sugammadex, mecaserim rinfabate, A-001, beclomethasone, clobazam, fludarabine tablets, JZP-8, and AST-120

FDA approved nebivolol on December 17, 2007, as monotherapy or in combination with other antihypertensive agents for the treatment of hypertension.