|Name/Company||Approval Dates and Comments|
The US FDA approved this new first-in-class human monoclonal antibody in March 2011 for the treatment of systemic lupus erythematosus (SLE). Treatment is indicated for adult patients with active, autoantibody-positive SLE who are receiving standard therapy. The drug inhibits the biological activity of the B-lymphocyte protein (BLyS). Elevated levels of BLyS are associated with autoimmune disorders and are believed to contribute to the production of autoantibodies that attack and destroy the body’s own healthy tissues. The recommended dosing regimen is 10 mg/kg by intravenous infusion at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. It is the first new lupus drug to receive regulatory approval in more than 50 years.
The US FDA approved this human monoclonal antibody in March 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 and allowing the immune system to recognize, target, and attack cells in melanoma tumors. Regulatory approval was based on a study of 676 patients with late-stage melanoma that showed better overall survival with ipilimumab compared with an experimental tumor vaccine (median survival was 10 months vs. 6.5 months). Common autoimmune side-effects included colitis, diarrhea, endocrine dysfunction, fatigue, and skin rash. Additionally, severe to fatal autoimmune reactions were observed in 12.9% of ipilimumab-treated patients. Due to the unusual and severe side-effects, approval is accompanied by an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) to inform health care professionals about these serious risks.
Health Canada approved this immune response modifier in March 2011 for the topical treatment of external genital warts and perianal warts in patients =18 years of age. Under clinical investigation, Vyloma™ showed that the once-daily treatment regimen for up to 8 weeks was safe and provided sustained efficacy.
In March 2011, the US FDA announced the approval of an expanded age indication for the live, attenuated varicella zoster virus (VZV) vaccine (Zostavax®) for the prevention of herpes zoster infection (shingles) in individuals 50 to 59 years of age. The vaccine was originally approved in May 2006 for the prevention of herpes zoster in individuals =60 years of age. Approval of this expanded indication was based on findings from the Zostavax Efficacy and Safety Trial (ZEST), a multicenter placebo-controlled, double-blind study involving 22,439 subjects aged 50 to 59 years, who were randomized to receive a single dose of either the VZV vaccine (n=11,211) or placebo (n=11,228). Study participants were monitored for the development of shingles for at least 1 year. Compared with placebo, VZV vaccination reduced the risk of developing shingles by 69.8%.