www.fdanews.com/articles/200163-alynlams-ph1-therapy-wins-approval-in-europe
Alynlam’s PH1 Therapy Wins Approval in Europe
November 24, 2020
Alynlam Pharmaceuticals has received marketing authorization in Europe for Oxlumo (lumasiran) as a treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare orphan disease that can lead to renal failure.
Oxlumo is an RNA interference drug meant to halt production of oxalate, a disease-causing toxin that leads to PH1.
Alnylam has also submitted a New Drug Application to the FDA and has received a priority review with a target decision date of Dec. 3.