CHMP recommends change to indication for Simponi in Juvenile idiopathic arthritis.- Janssen Biologics.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the terms of the marketing authorisation for the medicinal product Simponi (golimumab) from Janssen Biologics. The CHMP adopted an extension to one of the existing indications for Simponi 50 mg solution for injection in pre-filled pens and syringes as follows:�Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis (pJIA) Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older who have responded inadequately to previous therapy with MTX.�
In addition, the CHMP recommended approval of a new formulation of Simponi, a 45 mg/0.45 ml solution for injection in pre-filled pens, for the above indication.
Simponi was approved in the EU for for the treatment of polyarticular juvenile idiopathic arthritis in 2016.
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