The independent website for Australian pharmacists

TGA gives green light to Simponi

27 November 2009 Print this article Comments Share this article

A new subcutaneous biologic therapy for treating rheumatoid and psoriatic arthritis, as well as ankylosing spondylitis, has been approved by the Therapeutic Goods Administration.

Simponi (golimumab) is a human monoclonal antibody designed to block tumour necrosis factor-alpha (TNF) and is indicated for the treatment of rheumatoid and psoriatic arthritis when treatment with disease-modifying anti-rheumatic drugs (DMARDs) has been inadequate.

According to manufacturer Schering-Plough, clinical studies involving more than 2,000 patients showed that Simponi reduced symptoms and improved physical functions for sufferers.

The once-monthly 50mg subcutaneous injection is available in either the SmartJect autoinjector or a prefilled syringe form, allowing patients to self-administer at home after training and approval by a health care professional.

"Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are incredibly painful diseases which often have a devastating impact on patients' quality of life and independence," said rheumatologist Dr Stephen Hall from Cabrini Health in Melbourne.

"Sadly, these diseases tend to affect people in their prime. The availability of Simponi should make a difference to many of our patients who battle every day with relentless pain, extreme fatigue and loss of mobility.

"This new treatment offers patients a once-monthly dosing regime that they can self-administer and produces few injection site reactions."

While Simponi can be taken alone for the treatment of ankylosing spondylitis and psoriatic arthritis, it is only approved for treatment of rheumatoid arthritis together with methotrexate.


Tags: arthritis


Add a comment

Add a new comment

Enter the code shown:

Recent newsletters

Newsletter archive

Recent comments

Most viewed articles this week

Related sites