Alnylam promises swift access after Oxlumo EMA approval

RNAi therapeutics company Alnylam Pharmaceuticals (Nasdaq: ALNY) has announced that the European Commission (EC) has granted marketing authorization for Oxlumo (lumasiran), its treatment of primary hyperoxaluria type 1 (PH1) in all age groups.

The decision comes after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended Oxlumo for approval last month.

"Alnylam is committed to being as innovative commercially as we have been scientifically"John Maraganore, chief executive, Alnylam, said: “Prior to now there have been no approved treatment options for PH1 in Europe, so this is a potentially life-changing milestone for people diagnosed with this ultra-rare, debilitating disease – many of whom are infants and children – and their families. Lumasiran will address the urgent unmet need that exists for patients with PH1 and its approval today marks our continued commitment to rare disease communities.