ClassName/CompanyApproval Dates and Comments
Rheumatoid ArthritisCertolizumab 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.

Psoriatic ArthritisGolimumab

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 AgentCeftobiprole medocaril
Basilea Pharmaceuticals

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 AIDSTipranavir

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.

Drug News
New Guidelines

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:

  • their condition has not improved with other treatments, such as cyclosporin, methotrexate, and psoralen + long-wave ultraviolet radiation (PUVA).
  • they have experienced side-effects with these treatments in the past
  • there is a medical reason why they should not receive these treatments.

Treatment with adalimumab should only be continued beyond 16 weeks only if the psoriasis has clearly improved within this time.
The severity of a patient’s psoriasis before and during treatment should be assessed by considering the redness, thickness, and scaliness of the plaques, as well as the area of the body involved, and how the condition affects the person’s quality of life. When assessing a patient’s psoriasis, healthcare professionals should take into account any disabilities or difficulties in communication, as poor communication may indicate that standard assessments will not provide accurate information about the patient’s condition.