Drug Pipeline

FDA Amendments Act of 2007 included provisions for sponsors to submit Risk Evaluation and Mitigation Strategies for select pharmaceuticals, if FDA considered it necessary to ensure that its benefits outweigh its risks.

On March 10, 2010, FDA announced that its review of data requested in June 2008 from all bisphosphonate drug manufacturers did not suggest an increased risk of subtrochanteric femur fractures (bone breaks just below the hip) in those receiving oral bisphosphonates.

Chemoprevention with dutasteride (a 5-alpha reductase inhibitor or 5-ARI), given at a dose of 0.5 mg daily, reduced the risk of incident prostate cancer detected on biopsy and improved outcomes related to benign prostatic hyperplasia, according to the results published in the April 1, 2010, edition of the New England Journal of Medicine.

The massive health reform legislation approved by Congress in March promises to significantly expand the number of Americans with healthcare coverage and pharmacy benefits.

"At-risk" generic launches refer to generic pharmaceuticals that are approved by FDA based on the review of an abbreviated new drug application (ANDA) and are subsequently launched while patent litigation is ongoing.

New indication: Rifaximin (Xifaxan) was approved in March 2010 for the reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age.

FDA granted marketing approval for a new formulation of controlled-release oxycodone (OxyContin, Purdue Pharma) on April 5, 2010.

New Formulation: Doxepin (Silenor) was approved in March 2010 for the treatment of insomnia.

According to a systematic review in the April 13, 2010 edition of the Journal of the American Medical Association, noninsulin antidiabetic drugs show similar reductions in glycosylated HbA1c when used in combination with metformin in type 2 diabetics, but differ in their rates of hypoglycemia and weight gain.

Clinical studies of patients with both ST-elevation and non-ST-elevation acute coronary syndromes have shown that ticagrelor, when compared with clopidogrel, reduces the rates of vascular death and myocardial infarction while increasing the rate of non-coronary artery bypass graft-related major bleeding. Ticagrelor was also associated with a higher incidence of dyspnea and ventricular pauses.

Generic drugs approved by FDA (through April 2010): Losartan potassium tablets in 25-mg, 50-mg, and 100-mg, Losartan potassium and hydrochlorothiazide tablets in 50 mg/12.5 mg, 100 mg/12.5-mg, and 100 mg/25 mg, Hydromorphone hydrochloride injection, Mesna injection

Recent FDA approvals (through April 2010) related to Zortress, OxyContin, Exalgo, Kaletra, Provenge, Dacogen, Asclera, Pancreaze, Tarceva, Oravig

On March 12, 2010, FDA announced that the manufacturers of clopidogrel, an antiplatelet agent given to reduce the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease, will be placing a new black box warning into the drug's prescribing information.

New molecular entity: Velaglucerase alpha for injection (VPRIV) was approved February 2010 as an enzyme replacement therapy for the long-term treatment of type 1 Gaucher disease in pediatric and adult patients.

A randomized controlled trial of recent stroke survivors found that patients receiving the selective serotonin reuptake inhibitor escitalopram had greater improvement in global cognitive function than those receiving placebo or Problem Solving Therapy.

Generic drugs approved by FDA (through February 2010): Tamsulosin hydrochloride capsules, 0.4 mg, Imiquimod cream, 5%, Diltiazem hydrochloride extended-release tablets

Cardiovascular disease (CVD) remains the leading cause of death in patients with diabetes mellitus, accounting for 50% of all deaths. Dyslipidemia is an important modifiable risk factor in diabetic patients and represents a key area for intervention in these patients. Diabetic patients have a lipid profile characterized by low high-density lipoprotein cholesterol (HDL-C) levels and an increase in triglyceride levels. Diabetics have increased numbers of low-density lipoprotein cholesterol (LDL-C) particles but with a shift to smaller, denser LDL-C particles. The net effect is that patients with type 2 diabetes do not have substantially higher LDL-C concentrations than patients without diabetes.

New molecular entity: Dalfampridine (Ampyra) was approved in January 2010, as a treatment to improve walking in patients with multiple sclerosis.

Naproxcinod, a cyclooxygenase-inhibiting nitric oxide donor, is pending FDA approval for the indications of knee and hip osteoarthritis. Treating osteoarthritis pain can be challenging because many agents commonly used for this indication carry potential risk for increased cardiovascular events including increased blood pressure, increased upper gastrointestinal bleeding, and increased hepatotoxicity.

New added financial incentives are slated to drive adoption of electronic health record systems by doctors and hospitals, and increased government funding may finally lead to standards for interoperability and e-health exchanges necessary for the free flow of secure health data.

Recent FDA approvals (through April 2010) related to Silenor, Carbaglu, Hizentra, Norditropin FlexPro, Xifaxan, Differin, Botox

New molecular entity: Tocilizumab (Actemra) was approved in January 2010, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

Recent FDA approvals (through March 2010) related to Iprivask, VPRIV, Mirapex ER, Cayston, Menveo, Lamictal XR, Rituxan, Oleptro, Xiaflex, Norvir, Benicar, Crestor.

Venous thromboembolism (VTE) is a debilitating and potentially fatal condition, often seen in the aging population. VTE results from clot formation in the venous circulation and presents as either deep-vein thrombosis or pulmonary embolism. A population-based study estimated that at least 201,000 new cases of VTE occur in the United States annually.

Etravirine is an HIV-1 specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) that was FDA approved for treatment-experienced adult patients with HIV-1 strains resistant to an NNRTI and other antiretroviral agents. In phase 3 trials of etravirine versus placebo, both in combination with darunavir/ritonavir, a background of nucleoside/nucleotide reverse transcriptase inhibitors with or without enfuvirtide demonstrated potent antiviral activity that was sustained through 48 weeks.