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.

More information is available at: http://hc-sc.gc.ca/dhp-mps/medeff/advisoriesavis/ public/_2010/accutane_2_pc-cp-eng.php.