Skip to Content

Weekly Drug News Round Up - May 16, 2012

Gilenya Update: Safety Review of Death After First Dose

FDA unable to definitively conclude that Gilenya related to death Read More...

The U.S. Food and Drug Administration (FDA) has updated the package labeling of Gilenya (fingolimod), a multiple sclerosis (MS) treatment that was associated with a patient death within 24 hours of the patient taking their first dose. Previously, it was known that Gilenya could lower the heart rate within 6 hours of the first dose, but new evidence reveals the maximum effect may occur as late as 20 hours in some patients. Gilenya is now contraindicated in certain pre-existing heart conditions, stroke, or with some antiarrhythmic medications. FDA also recommends that providers extend cardiovascular monitoring past six hours in high-risk heart patients or those prone to bradycardia. Extended monitoring in high-risk patients should include continuous, overnight ECG monitoring.

Acne Treatment Fabior Foam Approved for 12 Years and Older

Fabior topical acne foam approved in patients 12 years of age and older Read More...

Fabior (tazarotene) Foam 0.1% has been FDA-approved for the treatment of moderate-to-severe acne vulgaris in patients 12 years of age and older. Fabior is a retinoid product with the same active ingredient as Tazorac cream or gel. Fabior approval was based on positive results from two Phase 3, vehicle-controlled studies. Fabior is contraindicated for use during pregnancy and may cause fetal harm. Women of childbearing potential should have a negative pregnancy test within two weeks prior to treatment initiation, and use a reliable method of contraception. Side effects occurring in greater than six percent of patients included application site reactions such as irritation, dryness, redness and exfoliation (sloughing of dead skin cells).

Once-Daily Quad Tablet Recommended by FDA Panel

FDA has an action date of August 27, 2012 to make a decision on the approval of Quad Read More...

In a 13-1 vote, the U.S. Food and Drug Administration (FDA) Antiviral Advisory Committee has recommended approval of Gilead’s Quad tablet for HIV treatment in treatment-naϊve patients. Quad is a complete, four drug regimen consisting of two new, investigational agents elvitegravir and cobicistat, combined with emtricitabine and tenofovir disoproxil fumarate in one tablet. In two Phase 3 studies Quad demonstrated non-inferiority to the comparative agents Atripla and ritonavir-boosted atazanavir plus Truvada. A non-inferiority trial may be used when using a placebo design is not an option (as in HIV). These trials seek to show that overall the new treatment is not worse (inferior) than the active comparator drug.

New Weight Loss Drug Okayed By FDA Advisory Panel

If lorcaserin is approved, it would be the first new weight loss drug treatment in 10 years Read More...

A U.S. Food and Drug Administration (FDA) advisory panel has recommended approval of lorcaserin, a selective serotonin 2C receptor agonist, even amid concerns about looming cardiovascular risks such as high blood pressure or heart valve damage. The advisory committee felt the benefits of the drug, which may be used for initial weight loss and longer-term maintenance, outweighed the possible risks. Lorcaserin has been evaluated in three placebo-controlled, Phase 3 clinical trials in over 7,800 patients, including patients with type 2 diabetes. Statistically significant weight loss was achieved after one year, with headache being the most frequent side effect. The FDA has a target action date of June 27, 2012 for final approval status for lorcaserin.

Alzheimer Prevention: Groundbreaking Research Study Begins

Experimental drug to be tested in patients with genetic code for Alzheimer’s Read More...

In a $100 million, 5-year study, researchers will begin testing the investigational drug crenezumab in subjects that are disease-free at the outset, but genetically destined to develop Alzheimer’s disease. An extended family in Columbia, South America has the genetic mutation that puts them at high risk for developing early-onset Alzheimer’s, with symptoms starting at 45 years of age. Crenezumab, designed to attack the beta amyloid plaque thought to contribute to Alzheimer’s onset, will be tested in members of this family, as well as some Americans. Researchers hope to gain knowledge about the development and treatment of other types of Alzheimer’s, as well, which in total currently affects 5.4 million Americans.