|Name/Company||Approval Dates and Comments|
Human Genome Sciences/
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
The US FDA approved a generic version of adapalene 0.1% gel (comparable brand, Differin®, Galderma) in June 2010 for the treatment of acne.
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).
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
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.