Update on Drugs and Drug News - November 2007

UPDATE ON DRUGS
Class	Name/Company	Approval Dates and Comments
Antifungal Agent	Terbinafine hydrochloride Lamisil® Novartis Pharmaceuticals	The US FDA approved this antifungal agent in September 2007 for the treatment of tinea capitis in young children .4 years of age. The new granular formulation, which can be sprinkled on children�fs food, is intended to improve patient compliance and treatment outcomes. The recommended dosage is based on the child�fs weight and administered once daily for 6 weeks.
Antiviral Agent	Famciclovir TEVA Pharmaceutical Industries	The US FDA approved the first generic formulation of famciclovir (comparable brand, Famvir®, Novartis) in August 2007 for the treatment of herpes zoster (shingles).
Antibacterial Agent	Ceftobiprole BAL5788 Basilea Pharmaceutica/ Janssen-Ortho	Health Canada accepted a Review New Drug Submission for this antibacterial agent in September 2007 for the treatment of complicated skin and skin structure infections, including diabetic foot infections. Ceftobiprole is a novel broad-spectrum cephalosporin antibiotic effective against drug-resistant bacteria.

Drug News
Antipsoriatic Agent	During the recent World Congress of Dermatology meeting, lead investigator, Craig Leonardi, presented data from an international multicenter, randomized, double-blind placebo-controlled Phase III study, which showed that two-thirds of the subjects treated with the injectable medication, ustekinumab (CNTO 1275, Centocor/ Johnson & Johnson), experienced marked improvement in their psoriasis when compared with placebo. Ustekinumab is a novel fully-humanized monoclonal antibody that targets interleukin-12 and interleukin-23. These proteins are believed to play an integral role in immune-mediated inflammatory diseases, such as psoriasis. Over 1,200 patients with moderate-tosevere psoriasis were randomized to one of three treatment arms: one of two different doses of the study drug, or placebo. At week-12, as measured by the PASI, 76% of patients who were administered the higher dose, and 67% of those who received the lower dose, achieved at least 75% improvement in their symptoms, compared with only 4% in those who received placebo. Furthermore, approximately 50% of the subjects who were treated with the higher dose of the study medication experienced clearing of almost all psoriatic lesions, and exhibited substantial improvement in other associated symptoms, as compared with only 1% of the placebo group. Leonardi C, et al. CNTO 1275 (anti-Il-12/23p40) Treatment of psoriasis: phase 3 trial results. At the 21st meeting of the World Congress of Dermatology (October 1-5, 2007) Buenos Aires, Agrentina; Book 1, Abstract 1543.
US FDA Regulations	In September 2007, the US FDA has gained additional powers following the passage of a bill by the US Senate. The new legislation will enable the US FDA to require new warnings on approved prescription drugs if warranted; mandate the completion of post-approval studies; or limit its distribution in cases where concerns arise regarding a product’s safety. Fines for up to $10 million can be imposed for noncompliance. These changes were proposed in response to the recent controversial delayed handling by the US FDA of potentially severe or life-threatening side-effects that were linked to certain prescription medications. The new regulations are intended to improve postmarketing surveillance programs and place emphasis on long-term patient safety. Pharmaceutical companies will be required to announce results from clinical studies of marketed products in a public database. More information on the US FDA’s Drug Safety Initiative can be found at: http://www.fda.gov/cder/drugSafety.htm.

1. The Dermatology Dispensing Debate
2. Treatment of Hand and Foot Psoriasis with Emphasis on Efalizumab
3. Update on Drugs and Drug News - November 2007