Update on Drugs and Drug News - July-August 2006

UPDATE ON DRUGS
Class	Name/Company	Approval Dates and Comments
Antiviral Agent	Zoster Vaccine Live Zostavax® Merck	The US FDA approved this new vaccine in May 2006 for the prevention of herpes zoster (shingles) in individuals 60 years of age and older. It is given as a single dose by injection.
Rosacea	Doxycycline, 40mg Oracea® CollaGenex Pharmaceuticals	The US FDA approved this product in May 2006 for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients.
Antiaging Agent	Hyaluronic Acid Dermal Filler Juvéderm® Gel Allergan	The US FDA approved this dermal filler in June 2005 for the treatment of facial wrinkles and folds. Juvéderm® should only be administered by a trained and qualified health care provider.
Immunomodulatory Agent	Mycophenolate Mofetil CellCept® Aspreva Pharmaceuticals/Roche	The US FDA granted orphan drug designation for this immunosuppressive agent in June 2006 for the treatment of pemphigus vulgaris.
Oncologic Agent	Suberoylanilide Hydroxamic Acid (SAHA) Zolinza® Merck	The US FDA accepted a New Drug Application for this investigational histone deacetylase inhibitor in June 2006 for the treatment of advanced cutaneous T-cell lymphoma. This NDA has been granted priority review.
Vaccine	Quadrivalent Human Papillomavirus Recombinant Vaccine Gardasil® Merck	The US FDA approved this vaccine in June 2006 for the prevention of cervical cancer and vulvar and vaginal precancers caused by HPV types 16 and 18 and to prevent low-grade and precancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18.
TNF-blocking Agent	Adalimumab Humira® Abbott	The European Medicines Agency approved this tumor necrosis factor (TNF)-blocking agent in June 2006 for the treatment of severe ankylosing spondylitis.

Drug News
Antipsoriatic Agent	Twelve-week data were recently published* from a multinational, randomized, double-blind, placebo-controlled, parallel-group clinical study designed to evaluate the safety and efficacy of efalizumab (Raptiva®) 1.0mg/kg once weekly when compared with placebo. Investigators found that efalizumab produced significant clinical improvements and was generally well tolerated among patients with moderate-to-severe plaque psoriasis. *Dubertret L, Sterry W, Bos JD, et al. Br J Dermatol 155(1):170-81 (2006 Jul).
Treatment Resistance	According to a recent study of Welsh school children published in the Archives of Disease in Childhood*, four out of five head lice are resistant to common treatments containing pyrethroids (permethrin and phenothrin). Whether this pattern is reflected elsewhere will depend on how head lice treatments are used. However, they suggest that where resistance develops, a newer silicone based lotion might be a suitable alternative. *Thomas DR, McCarroll L, Roberts R, et al. Arch Dis Child [Epub ahead of print] (2006 June 14).

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3. Update on Drugs and Drug News - June 2006