|Approval Dates and Comments
|Bimatoprost Ophthalmic Solution 0.03%
The US FDA will be receiving a new drug application for this synthetic prostaglandin analog by the end of 2008 for a new indication. Bimatoprost is currently indicated for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension. In clinical studies, patients reported significant eyelash growth when the drug was applied directly to the eyelash bases. FDA approval is anticipated in 2009.
The US FDA extended the review timeline for the Biologic License Application for this subcutaneous biologic therapy by 3 months to December 2008 in order to provide additional time to review amendments to the application. This application seeks marketing approval for the treatment of adult patients with chronic moderate-to-severe plaque psoriasis. Ustekinumab is also under review by the European Medicines Agency (EMEA).
|p53 tumor suppressor therapy
The EMEA accepted for review a Marketing Authorization Application in August 2008 for this p53 tumor suppressor therapy for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck. If approved, this will be the first gene therapy product approved for use in Europe.
Health Canada approved this vaccine in August 2008 for the prevention of shingles in individuals aged 60 years or older. This vaccine is expected to become available sometime in 2009.
|Calcipotriene 0.005% + betamethasone dipropionate 0.064%
The EMEA approved this gel in August 2008 for the treatment of scalp psoriasis. The gel is expected to become available in Europe by late 2008.
The EMEA approved this product in a 50mg once weekly dosage regimen as an alternative to the currently approved etanercept 25mg twice weekly regimen for the treatment of patients with moderate-to-severe plaque psoriasis.
The US FDA announced in September 2008 that the manufacturers of Humira® (adalimumab, Abbott Laboratories), Cimzia® (certolizumab pegol, UCB), Enbrel® (etanercept, Amgen-Wyeth), and Remicade® (infliximab, Centocor) must strengthen the existing warnings in the Warnings and Precaution sections of each drug’s Prescribing Information and Medication Guide to include information about the risk of developing opportunistic fungal infections. Based on reports reviewed by the US FDA, health care professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment and as a result, some patients with invasive fungal infections have died. These drugs are known as tumor necrosis factor-á blockers and are approved to treat a variety of conditions, which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn’s disease.
In a small study published in a recent issue of the British Journal of Dermatology*, Perrett et al. found that azathioprine treatment was associated with an increase in ultraviolet A and solar-stimulated radiation sensitivity and a significant reduction in the minimal erythema dose. In addition, they also found that DNA from the skin of these patients contained 6-thioguanine, which supports the hypothesis that DNA 6-thioguanine interacts with UVA, resulting in abnormal cutaneous photosensitivity.
* Perrett CM, et al. Br J Dermatol 159:198-204 (2008).