ClassName/CompanyApproval Dates and Comments
Differin® Gel 0.1%
Galderma KK/ Shionogi

Japan’s Ministry of Health, Labour and Welfare approved this first-in-class topical retinoid in July 2008 for the treatment of acne vulgaris.

Actinic KeratosisMethyl Aminolevulinate
Hydrochloride Cream

Metvixia™ + Aktilite® CL128
Photocure ASA/ Galderma

The US FDA approved the combined use of this topical light sensitizing agent used in photodynamic therapy in June 2008 for the treatment of actinic keratosis. This novel therapy involves the local application of Metvixia™ in combination with Aktilite® CL128, which is an LED based narrow band (630 nm) red light technology device.

Dermal FillerCross-linked Collagen
ColBar LifeScience Ltd.

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.

Drug News
FDA Early Communication

Despite ongoing safety concerns surrounding the use of tumor necrosis factor (TNF) inhibitors, especially etanercept (Enbrel®, Amgen/Wyeth), a US FDA advisory panel voted in favor of approving the drug for use in children with moderate-to-severe psoriasis in June 2008. Current approved indications include children and adults with rheumatoid arthritis (RA) and adults with psoriasis. However, the favorable vote follows an FDA announcement in the same month that it intends to mandate stricter warnings on labels to draw attention to the risk of death in children and of moderate-to-severe infections in adults. These measures have been proposed following approximately 30 reports of cancer in children and young adults between 1998 and 2008. The agency’s Adverse Event Reporting System collects and monitors reports of serious malignancies, infections and neurological problems in children treated with TNF blockers, as well as other immunosuppressive drugs. The FDA is investigating the entire class of TNF antagonists for potential links to childhood cancers, especially lymphoma, in pediatric patients with juvenile RA and Crohn’s disease. Approved drugs under this class of agents include adalimumab (Humira®, Abbott Laboratories), etanercept (Enbrel®, Amgen/Wyeth), infliximab (Remicade®, Johnson & Johnson) and certolizumab pegol (Cimzia®, UCB).

Actinic Keratoses

Although many treatment options exist for actinic keratoses (AKs), those considered to be patient-preferred remain undefined. Tierney, et al.* explored patient perceptions and preferences in the management of AKs, including the comparison of photodynamic therapy (PDT) with other therapies. In 2005-2006, 45 patients in the Henry Ford Health System who received PDT for AKs were mailed a self-administered questionnaire. Several indicators for each treatment were surveyed, including recovery time, cosmetic appearance, patient cost, effectiveness, patient satisfaction, treatment option preference, and perceived burden of treatment. Study findings from 39 respondents revealed that a patient’s reported recovery time was significantly more likely to be 1 week or less for PDT when compared with cryotherapy (p=0.02) and surgical excision (p=0.02). Borderline significance was found for the improved cosmetic outcome in PDT vs. surgical excision (p=0.058), and for patient satisfaction with PDT compared with 5-fluorouracil (p=0.058). Patients significantly preferred PDT to 5-fluorouracil (p<0.001) or imiquimod (p=0.031). Even though the efficacy of lesion clearance with PDT for AKs has been well established in the literature, this is the first study to evaluate patient perception of the effectiveness, side-effect profile, and benefits of PDT in comparison with other standard treatment approaches for AKs. PDT was found to have equivalent or improved recovery times, cosmetic outcomes, patient satisfaction, and preference as a treatment for AKs by patients when compared with other options.
* Tierney EP, et al. J Cosmet Laser Ther 10(2):81-6 (2008 Jun).