Update on Drugs and Drug News: April 2010

Collagenase clostridium
histolyticum
XIAFLEX™

Auxilium Pharmaceuticals

The US FDA approved this novel, first-in-class,
orphan-designated biologic in February 2010 for
the treatment of Dupuytren’s contracture in adults
with a palpable cord. The injected enzymes dissolve
and weaken the contracted collagen cord. This new
treatment represents the only nonsurgical option for
Dupuytren’s disease.

HPV quadrivalent
recombinant vaccine
Gardasil®

Merck & Co.

Health Canada approved an additional indication
for this human papillomavirus (HPV) quadrivalent
(Types 6, 11, 16, and 18) recombinant vaccine in
February 2010 for the prevention of infection caused
by HPV types 6, 11, 16, and 18 and genital warts
caused by HPV types 6 and 11 in boys and men 9-26
years of age.

Velaglucerase alfa
VPRIV™

Shire plc

The US FDA approved this hydrolytic lysosomal
glucocerebroside-specific enzyme in February 2010
for long-term enzyme replacement therapy for
pediatric and adult patients with Type 1 Gaucher
disease.

Agalsidase alfa
REPLAGAL®

Shire plc

The US FDA granted Fast Track designation to
this human-cell-line-derived enzyme replacement
therapy in February 2010 for the long-term treatment
of Fabry disease.

Adalimumab
Humira®

Eisai Co., Ltd.

Japan’s Ministry of Health, Labour, and Welfare
approved this fully-human monoclonal anti-TNFalpha
antibody in January 2010 for the additional
indications of plaque psoriasis and psoriatic arthritis.

Health Canada and Hoffmann-La Roche Limited informed healthcare professionals
in February 2010 about important new safety information regarding the association
between isotretinoin (Accutane™) and cases of severe skin reactions. As of
November 6, 2009, based on the manufacturer’s global safety database, a total of
66 cases of severe skin reactions have been reported worldwide in both adults and
children. Although the majority of these cases involved other confounding factors,
an association between isotretinoin and these severe skin reactions cannot be ruled
out. Key updated safety information includes:

• There have been very rare post-marketing reports of severe skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) linked with the use of isotretinoin. Severe skin reactions include rash, especially if associated with fever and/or malaise or conjunctivitis (red or inflamed eyes, like “pink eye”); blisters on legs, arms or face and/or sores in mouth, throat, nose or eyes; and peeling skin. Severe skin reactions can start with mild non-specific symptoms such as fever, malaise, chills, aching muscles, headache, sore throat, or stinging eyes. It can take up to 3 days for the skin lesions to develop.
• These events may be serious and result in hospitalization, disability, or death.
• Patients should be monitored closely for severe skin reactions and discontinuation of isotretinoin should be considered if warranted.