Alnylam has announced FDA approval of supplemental new drug application for Oxlumo (lumasiran) in advanced primary hyperoxaluria type 1.

The leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved a label expansion for Oxlumo^® (lumasiran), an RNAi therapeutic administered via subcutaneous injection, now indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients.

Oxlumo is administered once a month for three months, then monthly for patients weighing less than 10 kg, and quarterly for patients weighing more than 10 kg.

The most common adverse reaction (reported in ≥20% of patients) is injection site reactions.