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FibroGen: Receives Fast Track Designation from FDA for Pamrevlumab

FibroGen has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for pamrevlumab to treat muscle fibrosis in Duchenne muscular dystrophy. This designation follows a review of the Phase 2 clinical data from a single-arm trial in non-ambulatory patients with Duchenne.

What is muscle fibrosis? Muscle fibrosis is the formation of excess connective tissue.

Connective tissue normally surrounds muscle fibres and is essential for muscle function, but the formation of excess connective tissue (muscle fibrosis) can impair muscle function. Fibrosis is a hallmark of muscular dystrophies, contributing to muscle weakness.

Connective tissue growth factor (CTGF) is a pro-inflammatory protein — it promotes inflammation, which plays an essential role in wound healing but can also lead to muscle fibrosis. The inhibition of CTGF can improve muscle function irrespective of the cause of fibrosis. Pamrevlumab is a human antibody that recognizes and binds to CTGF, rendering it inactive.

Pamrevlumab is currently being evaluated in two Phase 3 trials for the treatment of DMD.

Click here to read the full press release.

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

About FibroGen 

FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For more information, please visit www.fibrogen.com.

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