Drug Pipeline

The latest FDA action (through May 2007) related to armodafinil (Nuvigil), tacrolimus (Prograf), sipuleucel-T (Provenge), Etoricoxib (Arcoxia), AZD-103/ELND005 (Transition), rNAPc2, Satraplatin, and Ganciclovir

Levetiracetam (Keppra) is now approved by FDA as an antiepileptic agent for adjunctive therapy in treatment of primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy.

HepaGam B, a solution of hepatitis B immune globulin (human), is now approved by FDA for the prevention of hepatitis B recurrence after liver transplantation in HBsAg-positive patients.

The combination of sitagliptin/metformin is now approved by FDA to improve glycemic control in adult patients with type 2 diabetes mellitus.

Chronic kidney disease (CKD) affects 20 million Americans, and an additional 20 million are at increased risk for developing CKD. Anemia is a common complication in patients with CKD. Continuous erythropoiesis receptor activator (CERA) is a new erythropoiesis-stimulating agent (ESA) that is undergoing FDA review for the treatment of anemia in patients with CKD, including in those undergoing dialysis.

The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires September 30, 2007, has set the stage for congressional action on broader legislation to improve the handling of drug safety issues. Bills under consideration aim to expand FDA oversight by establishing new requirements for postmarket risk assessment, for posting active clinical trials and resulting study data, and for completing postmarket studies.

We propose using the results of pharmacodynamic Monte Carlo simulation studies as a surrogate marker for potential efficacy of antibiotic dosage regimens and applying these end points to the calculation of an incremental cost-effectiveness ratio (ICER).

One of the numerous factors shaping pharmacy and therapeutics (P&T) committees' operations and decisions is the push for electronic health information systems, including electronic prescribing (e-prescribing). E-prescribing is expected to help prescribers comply with plan formularies and formulary policies.

In patients with metastatic renal cell carcinoma, treatment with sunitinib yields longer progression-free survival rates and a better health-related quality of life than does the standard treatment, interferon alfa therapy, according to the results of a phase 3 trial published in the New England Journal of Medicine (NEJM). A total of 750 patients aged ≥18 years participated in this international, multicenter, randomized trial.

Maintaining treatment with imatinib as initial therapy in patients with chronic myeloid leukemia (CML) may yield positive outcomes, including increased overall survival to ≥5 years, according to a study published in the New England Journal of Medicine (NEJM). The follow-up study of the International Randomized Study of Interferon and ST1571 (IRIS), a multicenter, international, randomized, phase 3 trial, included patients aged 18 to 70 years diagnosed with Ph-positive CML in chronic phase within 6 months before the start of the study.

In a randomized double-blind, parallel- group trial, salmeterol plus fluticasone failed to reduce all-cause death in patients with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) compared with each of the agents alone or placebo. The results of the Towards a Revolution in COPD Health (TORCH) trial were published in the New England Journal of Medicine (NEJM).

Healthcare professionals assembled at the 56th Annual Scientific Session of the American College of Cardiology (ACC) from March 24 to 27, 2007, in New Orleans, La, to exchange information and updates about new and continuing research in cardiovascular disease.

The rate of anticoagulant-associated intracerebral hemorrhage has increased dramatically since 1988, according to an observational study published in the journal Neurology. Researchers identified all patients hospitalized with first-ever intracerebral hemorrhage (ICH) in the 5-county Greater Cincinnati, Ohio/Northern Kentucky area during 3 unique time periods.

A discussion of new FDA-approved indications and formulations of drugs

A discussion of generic drugs recently approved by FDA

A discussion of drugs under consideration/review for FDA approval

Recombinant monoclonal antibody approved for reducing the signs and symptoms and inducing and maintaining clinical remission of moderately-to-severely active Crohn's disease

Recombinant monoclonal antibody approved for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis

4-anilinoquinazoline kinase inhibitor approved in combination with capecitabine for the treatment of advanced or metastatic breast cancer

Oral renin inhibitor approved as monotherapy or in combination with other antihypertensive agents for the treatment of hypertension

The Institute of Medicine (IOM) issued a report in September 2006 urging FDA to make major changes to better balance the agency's assessment of the risks and benefits of new drugs. FDA commissioner Andrew von Eschenbach, MD, has responded with a report that details the agency's plans to improve procedures for detecting and assessing drug safety problems. "The Future of Drug Safety" describes proposals for developing safety "report cards" on new drugs to better inform prescribers and patients about new safety concerns and to more quickly detect drug safety signals.

Due to pressure from regulators, the pharmaceutical industry is working to implement Radio Frequency Identification (RFID) technology in pharmacies, hospitals, and healthcare facilities to help prevent medication errors. This technology is also being used in a variety of ways to help meet FDA drug pedigree requirements.

Drugs that act to increase dopamine activity are the mainstay of pharmacologic treatment for restless legs syndrome (RLS), a sensomotor disorder that usually manifests as an urge to move the legs, with or without other uncomfortable sensations.

Combination therapy with an antimuscarinic agent (tolterodine extended release [ER]) and alpha1-receptor antagonist (tamsulosin) provided symptomatic benefit in men with moderate-to-severe lower urinary tract symptoms and overactive bladder, according to a large-scale, randomized, double-blind, placebo-controlled study published in the Journal of the American Medical Association (JAMA).

A public forum scheduled this month will help to solidify proposals FDA unveiled in January for reauthorization of the Prescription Drug User Fee Act (PDUFA). Once public comment from the February 16 meeting is received and incorporated into the finalized proposal, negotiations between the agency and the federal government over the fourth incarnation of this important funding mechanism will be key in determining FDA's fiduciary future.