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Update on Drugs and Drug News - February 2006




Approval Dates and Comments



The US FDA accepted a NDA in October 2005 for this orally administered, systemically delivered drug for the treatment of rosacea.

Atopic Dermatitis Agent

Hydrogel Dressing
MimyX™ Cream
Stiefel Laboratories

The US FDA approved this topical nonsteroidal treatment in October 2005 for the treatment of atopic dermatitis in patients of all ages. This product provides a new approach for treating AD by restoring the natural structure and components of the stratum corneum, helping to repair and restore skin barrier function.

Anti-aging Treatment

Aluma™ Skin Renewal System with FACES™

The US FDA approved this new technology in October 2005 for the noninvasive treatment of fine lines and wrinkles. The FACES™ technology combines radiofrequency energy with a vacuum to allow superficial as well as deep dermal heating for effective treatment with a very low risk of adverse events.

Antipsoriatic Agent

Clobetasol Propionate
CLOBEX® Spray 0.05%
Galderma Laboratories

The US FDA approved this super-high potency corticosteroid in October 2005 for the treatment of moderate-to-severe plaque psoriasis. This product comes in a non-aerosol spray formulation.

Antipsoriatic Agent

REMICADE® Centocor

The US FDA accepted a supplemental Biological License Application (sBLA) in November 2005 for the treatment of moderate-to-severe plaque psoriasis.

Drug News

Oncologic Agent

In October 2005, the independent Data and Safety Monitoring Board (DSMB) recommended that Cancervax and Serono discontinue their Phase 3 clinical trial of Canvaxin™ in patients with Stage III melanoma. The DSMB found that the data are unlikely to provide significant evidence of an overall survival benefit for patients with Stage III melanoma who were treated with Canvaxin™ vs. those who received placebo. These clinical trials were not discontinued because of any potential safety concerns

Drug Warning

A black box warning was added to the package labeling in the US for the small pox vaccine Dryvax®. The new warning alerts prescribers to the incidence of acute myopericarditis in healthy volunteers. Ischemic cardiac events and fatalities have occurred, but the relationship between these events and the vaccine isn’t known. Because of the potential risk, nonemergency use of Dryvax® isn’t recommended for patients with risk factors for cardiac disease.

Melanoma Research

Researchers at Northwestern University recently discovered a key signaling mechanism that may promote the ability of highly aggressive malignant melanoma cells to metastasize from a primary tumor to distant sites within the body.* They found elevated activity of an enzyme known as focal adhesion kinase (FAK) in aggressive melanoma cells that correlated with the cells’ increased invasion, migration and vasculogenic mimicry behaviors. When FAK signaling was blocked in these cells, they found a reduction in these activities suggesting a new mechanism for promoting melanoma spread. This could provide new insights into possible therapeutic intervention strategies. FAK is important for many cellular processes including cell survival, invasion and migration.

*Cancer Res 65(21):9851-60 (2005 Nov 1).

  1. Etanercept for the Treatment of Psoriasis
  2. Reduction of Face and Neck Laxity With Anchored, Barbed Polypropylene Sutures (Contour Threads™)
  3. Update on Drugs and Drug News - February 2006
  4. Index to Skin Therapy Letter - Volume 10 Articles, Issues 1-10