UPDATE ON DRUGS | ||
| Class | Name/Company | Approval Dates and Comments |
Antineoplastic Agent | Diclofenac Sodium 3% Gel Solaraze® SkyePharma | 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% Altabax™ GlaxoSmithKline | 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 Radiesse® 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% PV-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 STA-4783 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). |
