ClassName/CompanyApproval Dates and Comments

Antineoplastic Agent
Diclofenac Sodium 3% Gel
The Australian Government Department of Health and Ageing Therapeutic Goods Administration approved this antineoplastic drug in November 2006 for the management of actinic keratoses.

Antibacterial Agent
Retapamulin Ointment 1%
The US FDA issued an approvable letter in December 2006 for this topical antibacterial for the treatment of secondarily-infected traumatic lesions. This type of infection is most commonly caused by Staphylococcus aureus and Streptococcus pyogenes.

Skin Filler
Calcium Hydroxylapatite Microspheres in Water-based Gel
BioForm Medical
The US FDA approved this cosmetic dermal filler in December 2006 for two indications: for the long-lasting correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds, and for the long-lasting correction of lipoatrophy in people with HIV.

Oncologic Agent
Rose Bengal Disodium 10%
Provectus Pharmaceuticals
The US FDA granted Orphan Drug designation to this anti-cancer drug in January 2007 for the treatment of metastatic melanoma.

Oncologic Agent
Taxane Potentiator
Synta Pharmaceuticals
The US FDA granted Fast Track designation in November 2006 for this oncology drug candidate for the treatment of metastatic melanoma.

Drug News

Systemic Lupus Erythematosus
The initiation of dosing in pivotal Phase 3 clinical trials of belimumab (LymphoStat-B®, Human Genome Sciences/ GlaxoSmithKline) in patients with active systemic lupus erythematosus (SLE) has been announced. In each of the two Phase 3 trials, approximately 810 patients will be enrolled and randomized to 1 of 3 treatment groups (1mg/kg belimumab, 10mg/kg belimumab, or placebo). Patients will be dosed intravenously on Days 0, 14, and 28, then every 28 days for the duration of the study, and the first trial, BLISS-76, is expected to continue for 76 weeks. The data from BLISS-76 will be analyzed after 52 weeks in support of a potential Biologics License Application (BLA). The second Phase 3 trial, BLISS-52, is a 52-week study expected to begin in the first half of 2007.

Antipsoriatic Agent
Phase 2 data published recently in the New England Journal of Medicine* showed that patients with moderate-to-severe plaque psoriasis receiving subcutaneous injections of a human interleukin-12/23 monoclonal antibody (CNTO 1275, Centocor) experienced significant clearance of skin disease and significant improvements in quality of life. At week-12 of the study, 81% of patients receiving four weekly 90mg doses of this monoclonal antibody achieved at least 75% improvement in their psoriasis, as measured by the Psoriasis Area Severity Index (PASI 75), compared with 2% of patients receiving placebo. In addition, significantly more patients in each of the three additional CNTO 1275 dosing groups achieved at least a PASI 75 improvement in their psoriasis vs. patients receiving placebo. This fully human monoclonal antibody targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), and is currently in Phase 3 development for the treatment of moderate-to-severe plaque psoriasis.
*Krueger GG, et al. N Engl J Med 356(6):580-92 (2007 Feb).