Update on Drugs and Drug News

Update on Drugs and Drug News – September 2006

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STL Volume 11 Number 7

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September 1, 2006

UPDATE ON DRUGS
Class	Name/Company	Approval Dates and Comments
Vaccine	Quadrivalent Human Papillomavirus Recombinant Vaccine GARDASIL^® Merck	The Committee for Medicinal Products for Human Use in Europe recommended approval of this vaccine in July 2006 for the immunization of children and adolescents aged 9–15 years and of adult females aged 16–26 years for the prevention of cervical cancer, high-grade cervical dysplasia (CIN 2/3), high-grade vulvar dysplastic lesions (VIN 2/3) and external genital warts caused by human papillomavirus types 6, 11, 16, and 18. In June 2006 the US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices voted unanimously to recommend that girls and women 11–26 years of age be vaccinated with this product to prevent cervical cancer, precancerous and low-grade lesions, and genital warts caused by the human papillomavirus types listed above. GARDASIL® is a readyto- use, three dose, intramuscular vaccine.
Antipsoriatic Agent	Infliximab Remicade^® Centocor	The US FDA accepted a supplemental Biologics License Application in June 2006 for this product for inhibiting the progression of structural damage and improving physical function in patients with active psoriatic arthritis.
	Humira^® Pen Abbott Pharmaceuticals	The US FDA approved a new device for administering Humira® in June 2006. Humira^®is approved for the treatment of moderate-tosevere rheumatoid arthritis and psoriatic arthritis. This new device offers improved ease of use with its one-touch activation and easyto- grasp size and shape.
Drug News
Malignant Melanoma Research	Researchers from the Dana-Farber Cancer Institute have identified a novel gene that facilitates the spread of malignant melanoma using a technique that they believe can speed the discovery of hard-to-find cancer genes. Recently reported in Cell, the gene, NEDD9, is abnormally abundant in more than a third of melanomas that have metastasized, but not in primary melanomas that have not spread. The investigators used genome-scanning methods, such as array-CGH (comparative genomic hybridization), to uncover structural abnormalities of the chromosomes of cancer cells. Kim M, Gans JD, Nogueira C, et al. Cell 125(7):1269-81 (2006 Jun).
Scleroderma Research	In a bold attempt to control scleroderma, physicians at Duke University Medical Center are leading a national study to test whether stem cell transplants can reconstruct defective immune systems. At this time, the predominant therapy for this disease is cyclophosphamide; however, about 50% of patients with severe organ involvement die within 5 years of diagnosis. This study (Scleroderma Cyclophosphamide or Transplantation – SCOT) will increase the dose and duration of cyclophosphamide and compare this regimen against stem cell transplants, using purified cells derived from a patient’s own blood. This 7-year randomized clinical trial will enroll 226 patients at 36 institutions throughout the US. If successful, the therapy would represent the first therapy ever to treat and potentially reverse the disease itself, not just alleviate its symptoms.