Loargys (pegzilarginase) receives positive opinion by the CHMP for treatment of arginase 1 deficiency.-Immedica Pharma
Immedica announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization of Loargys (pegzilarginase) for the treatment of arginase 1 deficiency (ARG1-D) in patients two years and older.
The positive opinion from the CHMP is now referred to the European Commission for a decision.
Anders Edvell, CEO of Immedica commented: “Today’s announcement demonstrates significant progress towards providing the first disease modifying treatment for ARG1-D. The unmet medical need in this vulnerable patient population is huge and we look forward to the decision by the European Commission.
The opinion is based on data from the clinical development program of pegzilarginase for ARG1-D providing evidence of clinically relevant outcomes and balanced safety profile, including the phase III randomized, double-blind, placebo-controlled study named PEACE (CAEB1102-300A), supported by the phase II open-label long-term study (CAEB1102-102A).
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