Amgen's (AMGN) Uplizna has received a positive opinion from the European Medicines Agency's (EMA) human medicines committee recommending its approval for adults with active immunoglobulin G4-related disease, a rare autoimmune disorder with no authorized treatments in the EU.
The recommendation was based on a phase 3 study of 135 patients that showed Uplizna significantly reduced disease flares compared with placebo, the EMA said Friday.
At 52 weeks, 58.8% of patients on Uplizna achieved corticosteroid-free remission without flares versus 22.4% of those on placebo, according to the statement.
The regulator said safety findings were consistent with its use in neuromyelitis optica spectrum disorders, for which Uplizna is already approved. The most common side effects included infections, joint and back pain, and low lymphocyte counts, it added.
The EMA said the committee's opinion will be forwarded to the European Commission, which will decide on an EU-wide extension of the indication, while national pricing and reimbursement decisions will follow if approval is granted.
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