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Update on Drugs and Drug News: July-August 2010


Name/Company Approval Dates and Comments

Belimumab
Benlysta®
Human Genome Sciences/
GlaxoSmithKline

The US FDA and European Medicines Agency (EMA) received a Biologics License Application and Marketing Authorization Application, respectively, in June 2010 for the approval of this human monoclonal antibody for the treatment of systemic lupus erythematosus. Belimumab specifically targets and inhibits the activity of B-lymphocyte stimulator (BLyS®). Elevated levels of BLyS® prolong B cell survival, contributing to autoantibody production. Belimumab reduces autoantibody levels and controls disease activit

Adapalene 0.1% gel
TEVA Pharmaceutical Industries

The US FDA approved a generic version of adapalene 0.1% gel (comparable brand, Differin®, Galderma) in June 2010 for the treatment of acne.

Antiseborrheic compound
K301/Kaprolac®
Moberg Derma AB

In April 2010, marketing authorization in the European Union was granted to this novel non-prescription topical solution for the management and relief of scaly and itchy skin associated with common scalp conditions (e.g., seborrhoeic eczema and dandruff).


Drug News

Ipilimumab (MDX-010 or MDX-101) is a fully human antibody that binds to cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), a molecule on T-cells that plays a central role in immune response regulation. Ipilimumab inhibits the activity of CTLA-4, resulting in sustained antitumor immunity. A phase 3 study* of 676 patients with unresectable stage III or IV melanoma were randomly assigned (3:1:1 ratio) to receive ipilimumab + glycoprotein 100 (gp100) peptide vaccine (403), ipilimumab alone (137), or gp100 alone (136). Ipilimumab, at a dose of 3 mg/kg body weight, was administered with or without gp100 every 3 weeks for up to four treatments. The median overall survival was 10.0 months in patients receiving ipilimumab + gp100, as compared with 6.4 months in patients receiving gp100 alone (hazard ratio [HR] for death, 0.68; p < 0.001). The median overall survival with ipilimumab alone was 10.1 months (HR for death in the comparison with gp100 alone, 0.66; p = 0.003). No difference in overall survival was observed between the ipilimumab groups (HR with ipilimumab + gp100, 1.04; p = 0.76). Grade 3 or 4 immune-related adverse events occurred in 10-15% of patients treated with ipilimumab and in 3% treated with gp100 alone. Both ipilimumab treatment arms demonstrated significant overall survival benefit in patients with metastatic melanoma.
*Hodi FS, et al. N Engl J Med (2010 Jun 14) [e-pub ahead of print].

In August 2010, acitretin (Soriatane®, Tribute Pharmaceuticals) will be reintroduced in Canada. Acitretin is a synthetic oral retinoid and is indicated for the treatment of severe psoriasis (including erythodermic and pustular types) and other keratinizing disorders in patients who are refractory or intolerant to conventional therapies.

In April 2010, eflornithine hydrochloride (HCl) cream 13.9% (Vaniqa®, Triton Pharma Inc.) was re-launched in Canada as the only topical agent indicated for the reduction of unwanted facial hair in women. Eflornithine HCl cream can also be used in combination with laser therapy or in the management of hirsutism.


In this issue:

  1. Systemic Retinoids: Chemoprevention of Skin Cancer in Transplant Recipients
  2. Chemotherapy-Induced Hair Loss
  3. Update on Drugs and Drug News: July-August 2010