Alnylam Granted FDA Early Approval of GIVLAARI™ for AHP
Alnylam’s (ALNY) stock outperformed as its subcutaneous injection GIVLAARI™ (givosiran) has been granted FDA early approval. GIVLAARI™ is created and developed for the treatment of adults with acute hepatic porphyria (AHP). AHP is a family of ultra-rare, genetic diseases characterized by debilitating, life-threatening attacks and, for some patients, chronic manifestations that demeans patients’ daily functioning and quality of life. Long-term complications of AHP can include chronic neuropathic pain, hypertension, chronic kidney disease and liver disease.
In a clinical trial, GIVLAARI™ demonstrated a significant reduction in the rate of porphyria attacks that required hospitalizations, urgent healthcare visits or IV hemin administration at home.