Medical Specialties News

US Food and Drug Administration (FDA) has approved lumasiran subcutaneous injection

The US Food and Drug Administration (FDA) has approved lumasiran (Oxlumo, Alnylam Pharmaceuticals) subcutaneous injection to treat children and adults with primary hyperoxaluria type 1 (PH1), an ultra-rare genetic disorder that causes recurrent kidney stones and loss of kidney function.

“The approval of Oxlumo represents a great triumph of community involvement to address a rare disease. It is a result of input from patients, treating physicians, experts, and sponsors at a patient-focused drug development meeting and through other collaborative efforts,” Norman Stockbridge, MD, PhD, director, Division of Cardiology and Nephrology, FDA Center for Drug Evaluation and Research, said in a news release

Sandesh Ilhe
Sandesh Ilhe
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