|Class||Name/Company||Approval Dates and Comments|
|Rheumatoid Arthritis||Certolizumab pegol|
The European Medicines Agency (EMEA) has accepted for review a Marketing Authorization Application in July 2008 for this PEGylated anti-TNFá biologic therapy for the treatment of adults with moderate-to-severe rheumatoid arthritis. This antibody has been shown to reduce the rate of joint damage progression and improve physical function. Crohn’s disease is a US FDA-approved indication and development for psoriasis is currently underway.
The US FDA received a Biologics License Application in June 2008, requesting approval of this next-generation anti-TNF-a monoclonal antibody as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
|Antibacterial Agent||Ceftobiprole medocaril|
Health Canada authorized the marketing of this antibiotic in June 2008 for the treatment of complicated skin and soft tissue infections, including diabetic foot infections. Ceftobiprole is the first approved broad spectrum antimethicillin-resistant Staphylococcus aureus (MRSA) antibiotic belonging to the cephalosporin class.
|HIV and AIDS||Tipranavir|
The US FDA approved this oral formulation in June 2008 with dosing information for treatment-experienced pediatric patients aged 2 to 18 years who are infected with HIV-1. The recommended pediatric dose for both the capsules and oral solution is 14mg/kg with 6mg/kg ritonavir, or 375mg/m2 tipranavir coadministered with 150mg/m2 ritonavir. Prescribers should calculate the appropriate dose for each child based on body weight (kg) or body surface area (m2) and should not exceed the recommended adult dose of 500mg coadministered with 200mg ritonavir twice daily.
The National Institute for Health and Clinical Excellence of the UK National Health Service published new guidelines on the use of adalimumab for the treatment of psoriasis in adults. This product is recommended as a possible treatment for adults with plaque psoriasis only if:
Treatment with adalimumab should only be continued beyond 16 weeks only if the psoriasis has clearly improved within this time.