UPDATE ON DRUGS
|Class||Name/Company||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
|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.
|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.
CLOBEX® Spray 0.05%
|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.
|The US FDA accepted a supplemental Biological License Application|
(sBLA) in November 2005 for the treatment of moderate-to-severe
|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
|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.
|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).