EC Approves New Use for J&J’s Stelera
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Janssen-Cilag International NV, part of Johnson & Johnson, reports that the European Commission (EC) has approved Stelera (ustekinumab) for treating moderate-to-severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. The EC approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2015 recommending the use of Stelera for this indication.

Stelara, a human interleukin (IL)-12 and IL-23 antagonist, is approved for treating moderate-to-severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A (PUVA). It is indicated for the treatment of moderate-to-severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Stelara is also approved alone or in combination with MTX, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug therapy has been inadequate. The Janssen Pharmaceutical Companies maintain exclusive worldwide marketing rights to Stelara, which is currently approved for the treatment of moderate-to-severe plaque psoriasis in 84 countries and psoriatic arthritis in 55 countries.

Source: Johnson & Johnson

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