LMNL - FDA grants approval to Liminal BioSciences' Ryplazim treatment

Liminal BioSciences ([[LMNL]] -3.1%) announces that the U.S. FDA has approved Ryplazim for the treatment of patients with plasminogen deficiency type 1.The efficacy of the drug in pediatric and adult patients with plasminogen deficiency type 1 was evaluated in a single-arm, open-label trial.All patients received Ryplazim at a dose of 6.6 mg/kg administered every two to four days for 48 weeks to achieve at least an increase of individual trough plasminogen activity by an absolute 10% above baseline and to treat the clinical manifestations of the disease.The FDA had extended the review period for Ryplazim's BLA for the treatment of clinical signs and symptoms associated with congenital plasminogen deficiency ((C-PLGD)), in November last year.

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FDA grants approval to Liminal BioSciences' Ryplazim treatment