|Name/Company||Approval Dates and Comments|
The European Commission (European Medicines Agency) has approved this hydrolytic lysosomal glucocerebroside-specific enzyme (human cell line derived) in August 2010 for long-term enzyme replacement therapy in pediatric and adult patients with Type 1 Gaucher disease. Therapy is administered every other week by intravenous infusion. US FDA approval for this drug was granted in February 2010.
A vaginal gel containing tenofovir disoproxil fumarate (Viread®, Gilead Sciences Inc.), a nucleotide reverse transcriptase inhibitor, demonstrated protection against HIV/AIDS infection. The CAPRISA 004 trial investigated the efficacy and safety of tenofovir 1% vaginal gel for the prevention of HIV infection in women. Karim et al.* conducted a double-blind, randomized controlled trial comparing tenofovir gel (n=445) with placebo gel (n=444) in sexually active, HIV-negative females aged 18-40 years. Patients were instructed to administer one dose 12 hours pre-sex and a second dose as soon as possible within 12 hours after sex, but no more than two doses in a 24-hour period. The results reported were derived from monthly follow-up visits for 30 months. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at each study visit. HIV incidence in patients receiving tenofovir gel was 5.6 per 100 women-years, compared with 9.1 per 100 women-years in the placebo arm (incidence rate ratio=0.61; p=0.017). In the tenofovir gel treatment group, HIV incidence was reduced by 54% (p=0.025) in high adherers (gel adherence >80%), 38% in intermediate adherers (gel adherence 50-80%), and 28% in low adherers (gel adherence <50%); the overall reduction in HIV infection was 39%. No increase in the adverse event rates was observed between groups. If validated by further studies, this antiretroviral microbicide has the potential to significantly reduce AIDS risk in women.
*Karim QA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science (2010 Jul 19) [e-pub ahead of print].
Recently, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) issued updated recommendations on the human papillomavirus (HPV) bivalent (Cervarix®, GlaxoSmithKline) and quadrivalent (Gardasil®, Merck & Co., Inc.) vaccines. ACIP revisions include:
The updated recommendations are viewable at: http://www.cdc.gov/mmwr/PDF/wk/mm5920.pdf
Health Canada recently approved a labelling change for isopropyl myristate 50% rinse (Resultz®, Nycomed) to include the treatment of lice in children =2 years of age. This nonpediculicidal treatment has a physical mode of action that dissolves the outer layer of the exoskeleton, making resistance unlikely to develop.