Pfizer's Enbrel and Abbott's Humira are set to add new indications in arthritis-related conditions after being backed by a key European Medicine Agency (EMA) committee.
The Committee for Medicinal Products for Human Use (CHMP) gave positive opinions to Enbrel (etanercept) in several new areas of juvenile idiopathic arthritis (JIA) and to Humira (adalimumab) for additional uses in axial spondyloarthritis (AS), an inflammatory arthritis affecting the spine and/or pelvis.
Specifically, Enbrel is recommended to treat polyarthritis and extended oligoarthritis JIA in children from the age of two and in the treatment of psoriatic arthritis (PsA) in adolescents from the age of 12. Both indications are for patients for whom methotrexate is not a suitable treatment.
Enbrel is also recommended for use in the treatment of enthesitis-related arthritis (ERA) in adolescents from the age of 12 where conventional therapy hasn't worked or isn't suitable.
In addition, Pfizer's application seeks to add a once weekly dosing regimen to the approved twice-weekly dosing.
Humira has had its existing AS approval in adults who have not responded to conventional therapy expanded to cover treatment of the condition when there is no radiographic evidence of AS.
It can also be used in adults with severe cases of AS without radiographic evidence of AS but with signs of inflammation who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
CHMP decisions usually translate into full European approval within three months and these look set to be the latest in a long line of approvals for the rival drugs, both of which are TNF inhibitors used to treat autoimmine conditions by hindering the function of protein cells that cause inflammation.
Humira's extra indication would give the drug an advantage over Enbrel in AS, where Enbrel is only available when radiographic evidence is available. AS is more prevalent in men and is estimated to affect between two to five adults in every 1,000.
However, Enbrel could now have an advantage over Humira in JIA, where Humira has only received limited indications for the condition.
The condition, which involves the onset of arthritis in someone under 16 for no known reason, is thought to effect between 8 and 150 of every 100,000 children and is a significant cause of short- and long-term disability.
In a statement, Pfizer said: “This is an important development for Enbrel as it would provide a wider range of patients with access to this therapy. In a 12-week study of patients with eo-JIA, ERA, and PsA, Enbrel was shown to be effective in about three out of four children.”
Final decisions from the EC on both products are expected in the third quarter of 2012.
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