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Update on Drugs - February 2009

Name/Company Approval Dates and Comments

Basilea Pharmaceuticals

The French regulatory authority approved this retinoid in October 2008 for the treatment of severe chronic refractory hand eczema unresponsive to potent topical corticosteroids in adults. Also approved by the Danish Medicines Agency in September 2008. Marketing applications for this product are also under review in Canada and Switzerland.

Denileukin Diftitox
Esai Corporation

The US FDA approved this solution for intravenous injection in October 2008 for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor (CD25+).

Bimatoprost Ophthalmic 0.03% Solution

The US FDA approved this ophthalmic solution in Dec 2008 as a novel treatment for hypotrichosis of the upper eyelashes.


The US FDA approved this CCR5 antagonist in November 2008 for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretroviral agents.

Clindamycin Phosphate 1.2% + Benzoyl Peroxide 2.5%
Acanya® Gel
Arcutis Pharmaceuticals

The US FDA approved this fixed combination antibiotic and benzoyl peroxide formulation in November 2008 for the once daily treatment of both non-inflammatory and inflammatory acne lesions in patients 12 years of age and older.


The European Medicines Agency (EMEA) approved this product in January 2009 for the treatment of chronic severe plaque psoriasis in children aged 8 years and above.

Drug News

EMD Serono Canada issued new safety information in December 2008 for efalizumab (Raptiva®). This product has been associated with a risk of serious infections, including progressive multifocal leukoencephalopathy, a rare and sometimes fatal brain disorder. Efalizumab suppresses the body’s immune responses in order to reduce psoriatic inflammation, thus increasing the risk of infection in some patients. In October 2008 the US FDA announced that this product would require a black box warning about this risk of infection.

The US FDA issued a complete response letter in November 2008 to Johnson & Johnson Pharmaceutical Research for ceftobiprole for the treatment of complicated skin and skin structure infections including diabetic foot infections. In 2 large multinational, double-blind, randomized phase III clinical studies, this formulation showed that it was effective and met the primary endpoint using a 10% noninferiority margin. The safety profile was consistent with the cephalosporin class of antibiotics. However, the FDA indicated from their sponsor/ monitor inspection that there was a failure to ensure proper monitoring of the studies. The FDA requested information on the clinical quality assurance programs and also asked for a new audit plan that addresses deficiencies in contract research organization monitoring. The FDA further indicated that they will not review the clinical data included in the submitted complete response until issues of data integrity have been resolved. Johnson & Johnson must fully respond to this action letter within 1 year.

In this issue:

  1. Rosacea and Its Topical Management
  2. Drug Treatments for Skin Disease Introduced in 2008
  3. Update on Drugs and Drug News - February 2009