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Janssen receives CHMP backing for Stelara in psoriasis
Janssen has announced that its drug Stelara has been recommended for European regulatory approval as a treatment for psoriasis.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has backed Stelara for approval for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older.
Intended for individuals who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies, the drug has demonstrated its safety and efficacy in the phase III trial Cadmus.
A final decision from the European Commission is expected during the third quarter of 2015, with verdicts usually matching the CHMP recommendation.
Dr Newman Yeilding, vice-president and head of immunology development at Janssen Research and Development, said: "We look forward to the European Commission's decision and the opportunity to bring Stelara to adolescent patients who could benefit from biologic therapy."
This comes after the firm received a CHMP recommendation for approval of Simponi for the treatment of non-radiographic axial spondyloarthritis earlier this week.
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