Update on Drugs and Drug News: February 2009

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.

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+).

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.

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.

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.