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Silurian Pharmaceuticals, Inc. Announces that the Food and Drug Administration (FDA) Granted Brevenal Orphan Drug Designation for the Treatment of Cystic Fibrosis

Silurian Pharmaceuticals, Inc. Announces that the Food and Drug Administration (FDA) Granted Brevenal Orphan Drug Designation for the Treatment of Cystic Fibrosis

2018

Silurian Pharmaceuticals, Inc, received approval for its Orphan Drug Designation application in the USA for BREVENAL for the treatment of Cystic Fibrosis. The approval granted by the FDA for BREVENAL covers all Cystic Fibrosis (CF) patients with no limitations to any specific mutation subgroups.

BREVENAL is a disease modifying drug that significantly improves inhibited mucociliary clearance and reverses bronchoconstriction, commonly experienced by CF patients. Brevenalís effect is independent of the cystic fibrosis transmembrane conductance regulator (CFTR), the defective cause of CF disease. Brevenalís activity is seen across CFTR mutations including nonsense (X) mutations. BREVENAL is also additive to existing CFTR modulators.

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