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GSK: EU agency recommends new form for lupus drug.

(CercleFinance.com) - European regulators on Friday recommended an extension of therapeutic indications for a Glaxo medicine for the treatment of lupus.


The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a new pharmaceutical form for the drug, i.e. a solution for injection under the skin in a pre-filled syringe and pre-filled pen.

Benlysta's indications are for adult patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity, despite standard therapy.

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