Orencia wins expanded European licence
pharmafile | January 27, 2010 | News story | Sales and Marketing | BMS, Orencia, rheumatoid arthritis
BMS’s Orencia has been approved in Europe to treat children aged six and over who suffer from a form of arthritis.
It can be used in combination with methotrexate (MTX) for patients with moderate to severe polyarticular juvenile idiopathic arthritis (pJIA).
Children can be given Orencia (abatacept) if they have had an insufficient response to other DMARDS (disease-modifying anti-rheumatic drugs), including at least one tumour necrosis factor (TNF) inhibitor.
Like adult rheumatoid arthritis (RA), JIA is an autoimmune disease where the body mistakenly attacks healthy joint tissues causing chronic pain, stiffness and swelling.
The new approval is based on the AWAKEN study, structured in three parts, which looked at patients aged six to 17 years of age.
In the first phase patients received active treatment with Orencia, with 65%, 49% and 28% achieving an ACR Paediatric 30, 50 and 70, respectively.
The second was double-blind where patients with an ACR Paediatric (Pedi) 30 response were randomised to the drug or placebo.
Here, Orencia patients experienced fewer disease flares versus placebo (20% against 53%) and the risk of it among patients continuing was less than one-third than that for patients who withdrew.
The third was an open-label extension period open to patients experiencing flare or completing part two of the study as well as non-responders from part one.
Improvement in quality of life was also shown in a study where children missed fewer school days and parents were able to get back to their usual activities.
Orencia has not been studied in children under six years old, but was first approved by the European Commission for adult RA in May 2007.
T-cells are thought to play a major part in the development of JIA and Orencia is designed to prevent full T-cell activation, inhibiting the release of chemicals leading to joint inflammation and destruction.
It is a big seller for BMS: in the second quarter of last year, sales of the brand grew 40% worldwide to $148 million.
The leading drugs in the class are still the blockbusters – Wyeth and Amgen’s Enbrel, J&J’s Remicade, and Abbott’s Humira – but newer entrants such as UCB’s Cimzia and Orencia are providing competition.
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