welcome to DuchenneXchange
- a positively charged Duchenne muscular dystrophy community.- join today!
- log in
FibroGen Receives Fast Track Designation From the U.S. FDA for Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis
FibroGen, Inc., a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This follows review of the Phase 2 clinical data evaluating pamrevlumab in a placebo-controlled trial and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.
“This Fast Track designation reflects recognition of the great need for a new therapeutic to help patients diagnosed with IPF to reduce the burden and progression of this debilitating disease and another positive step in developing pamrevlumab for the treatment of IPF,” said Elias Kouchakji, M.D., Senior Vice President, Clinical Development and Drug Safety. “We look forward to advancing pamrevlumab into Phase 3 studies early next year.”

rareRelated
-
A Clinical Study to Assess Two Doses of GSK2402968 in Subjects With Duchenne Muscular Dystrophy (DMD)The purpose of this study is to determin...
-
Extension Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)This is an open-label, extension study o...
-
Ataluren: An Overview of Clinical Trial Results in Nonsense Mutation Duchenne Muscular DystrophyObjective: Provide an overview of atalu...
-
CureDuchenne Ventures Commits $500,000 to 4D Molecular Therapeutics to Advance Next-Generation AAV Delivery of Gene ...CureDuchenne, a national venture phila...
-
First Patient Dosed in Phase II Clinical Trial in Duchenne Muscular DystrophyAntisense Therapeutics today announced d...
-
A Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids, in Subjects With Non-ambulat...To evaluate the efficacy and safety of p...
-
Emerging drugs for duchenne muscular dystrophyDuchenne muscular dystrophy (DMD) is a r...
-
New CRISPR Method Takes on Duchenne Muscular DystrophyThe advance of CRISPR gene editing techn...