Posted by Michael Wonder on 28 Jul 2016
TGA approves Brenzys (etanercept)
28 July 2016 - The TGA has approved a biosimilar to Pfizer's Enbrel.
The TGA approved Brenzys on 22 July 2016 for use in adults 18 years and older for the treatment of:
- active, rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Brenzys can be used in combination with methotrexate.
- severe, active rheumatoid arthritis to slow progression of disease-associated structural damage in patients at high risk of erosive disease.
- the signs and symptoms of active and progressive psoriatic arthritis, when the response to previous disease-modifying antirheumatic therapy has been inadequate.
- patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.
the signs and symptoms of active ankylosing spondylitis.
- patients with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change who have had an inadequate response to NSAIDs.
Read TGA approval of Brenzys
Posted by:
Michael Wonder