|Class||Name/Company||Approval Dates and Comments|
|Scalp Psoriasis||Calcipotriene 0.005% +
0.064% Topical Suspension
Leo Pharma/ Warner Chilcott
The US FDA approved this topical suspension in May 2008 for the once daily treatment of moderate-to-severe psoriasis vulgaris of the scalp in adults =18 years of age. This new vehicle facilitates ease of use.
|Scalp Psoriasis||Calcipotriene 0.005%
Nycomed US, Inc./ Fougera
The US FDA approved the first generic formulation of calcipotriene scalp solution (comparable brand, Dovonex®, Leo Pharma/ Warner-Chilcott) in May 2008 for the topical treatment of chronic, moderately severe psoriasis of the scalp.
|Neurotoxin||Botulinum Toxin Type A
Medicis Pharmaceutical Corp./
The US FDA accepted a Biologics License Application in May 2008 to market this neuromuscular blocking agent for aesthetic indications. Marketing is anticipated to commence in the US during the second quarter of 2009.
A recent study by Fenner, et al.* explored the therapeutic efficacy of cephalexin in acne patients who were non-responsive to or unsuitable candidates for conventional therapies. Cephalexin is a broad-range, first-generation antibiotic of the cephalosporin class that is commonly used in the treatment of infections of the respiratory and urinary tracts. The study was a retrospective chart review of 93 patients, and the assessed aggregate data included patient demographics, history of therapies received, clinical response, and adverse effects. Clearance was noted in 4% of acne patients, 45% were considered to be much improved, 29% somewhat improved, 16% had no change, and 6% experienced worsening of symptoms at the first follow-up visit. The average length of treatment was 6 months. Analyses also revealed the prior use of systemic antibiotic(s) for acne by 84% of subjects; 7% experienced adverse effects. Study findings indicate that inclusion of cephalexin may be beneficial for treatment-refractory acne or in patients who are not suitable candidates, due to medical contraindications, for traditional therapies. Further investigations are warranted to confirm the safety and efficacy of cephalexin for the treatment of acne.
*Fenner, et al. Pediatr Dermatol 25(2):179-83 (2008 Mar-Apr).
Tumor necrosis factor-alpha blocking agents (anti-TNF-á) have been shown to be effective in the management of rheumatoid arthritis (RA), psoriatic arthritis, and psoriasis. Recent case reports describe the emergence of psoriasis as an adverse effect in RA patients undergoing anti-TNF-á treatment. The primary objective of the study was to ascertain if the incidence rate of psoriasis was higher in RA patients treated with TNF-á antagonists when compared with patients who received traditional disease modifying anti-rheumatic drugs (DMARDs). The rates of occurrence of psoriasis were also examined for 3 anti-TNF-á agents indicated for RA. The data analyzed was accessed from The British Society for Rheumatology Biologics Register. The study population consisted of 9,826 subjects treated with anti-TNF-á therapy and 2,880 subjects treated with DMARDs. For inclusion, each patient must have reported an adverse event that is defined as new onset psoriasis. Incidence rates of psoriasis were calculated as events per 1,000 person years and compared using incidence rate ratios (IRR). Findings revealed 25 cases of psoriasis were reported by anti-TNF-á treated patients vs. none by those receiving DMARDs; the rate of new onset psoriasis in TNF-á treated patients was higher at 1.04 (95% CI 0.67, 1.54) per 1,000 person years as compared with 0 (upper 97.5% CI 0.71) in those treated with DMARDs. Furthermore, a significantly higher incident rate was observed in patients treated with adalimumab as compared with those treated with etanercept (IRR 4.6 [95% CI 1.7, 12.1]) or infliximab (IRR 3.5 [95% CI 1.3-9.3]). Additional research is necessary to confirm these findings. The full article is viewable at: http://ard.bmj.com/cgi/rapidpdf/ard.2007.087288v1.
Harrison MJ, et al., Ann Rheum Dis, ARD Online First, published on April 2, 2008 (accessed June 1, 2008).