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Update on Drugs and Drug News: September 2011


Name/Company Approval Dates and Comments

Autologous cell therapy dermal filler
laVív® (azficel-T)
Fibrocell Science, Inc.

The US FDA approved the first novel personalized aesthetic cell therapy in June 2011 for improving the appearance of moderate to severe nasolabial folds in adults. In clinical investigations, this autologous cell therapy demonstrated good tolerability and the most common reported adverse events were mild to moderate injection-site reactions that resolved within 1 week. The technological platform used to create this product is a patented process that extracts, isolates, and multiplies a person's own skin cells (collagen producing fibroblasts), which are then injected into the wrinkles.

5-fluorouracil cream 0.5% + Salicylic acid 10%
Actikerall®
Almirall, S.A.

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing approval to this topical solution combination therapy in June 2011 for treating palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in adults. Good clinical efficacy was demonstrated in studies involving 168 patients, which confirmed histological clearance of lesions in 72% of patients and sustained clinical effect of 85.8% for lesions assessed as cleared after initial therapy and remained clear 12 months post-treatment.

Belimumab
Benlysta®
Human Genome Sciences GlaxoSmithKline

The European Commission (EC) has granted marketing authorization to this new first-in-class human monoclonal antibody in July 2011 for the treatment of systemic lupus erythematosus (SLE). Treatment is indicated for adult patients with active, autoantibodypositive SLE who are receiving standard therapy.

Ipilimumab
Yervoy™
Bristol-Myers Squibb

The European Commission (EC) has granted marketing authorization to this human monoclonal antibody in July 2011 for the treatment of metastatic melanoma. Administered intravenously, the drug blocks a T-lymphocyte antigen (CTLA-4), altering the body's ability to fight off cancerous cells.


Drug News

In June 2011, the US FDA notified healthcare professionals that the Warnings and Precautions section of labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of high-grade prostate cancer linked to the use of finasteride and dutasteride. This announcement follows the FDA's review of two large, randomized controlled trials - the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Finasteride (Proscar®/ Propecia®, Merck & Co.) and dutasteride (Avodart®/Jalyn™, GlaxoSmithKline) are used to treat male pattern hair loss and benign prostatic hyperplasia (BPH). Prior to initiating 5-ARI therapy, the FDA recommends physicians screen patients to rule out other urological conditions that can mimic BPH, including prostate cancer.
More information is available at: http://www.fda.gov/Drugs/DrugSafety/ucm258314.htm

In July 2011, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved three products by Merck Sharp & Dohme Idea Inc. (MSD), an affiliate of Merck & Co.:

  1. Gardasil® human papillomavirus quadrivalent (Types 6, 11, 16 and 18) recombinant vaccine is approved for the prevention of cervical cancer and their precursor lesions, vulvar and vaginal intraepithelial neoplasia grade 1/2/3, and genital warts caused by HPV types 6, 11, 16 and 18 in females ≥ 9 years of age.
  2. Zolinza® (vorinostat) is an oral anticancer agent approved for treating cutaneous T-cell lymphomas.
  3. Cubicin® (daptomycin for injection) is an antibacterial agent approved to treat methicillin-resistant Staphylococcus aureus (MRSA) infections.

In this issue:

  1. HPV Vaccine Update: New Indications and Controversies
  2. Botulinum Toxin Type A: New Information about an Old Medicine
  3. Update on Drugs and Drug News - September 2011