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The Food and Drug Administration (FDA) has approved Esbriet (pirfenidone; Genentech) and Ofev (nintedanib; Boehringer Ingelheim) for the treatment of idiopathic pulmonary fibrosis (IPF).
Esbriet is an orally active, small molecule that inhibits the synthesis of TGF-beta, a chemical mediator that plays a role in proliferation, differentiation, and fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine involved in inflammation. The safety and efficacy was established in three Phase 3 clinical trials of patients with IPF (n=1,247). Patients taking Esbriet demonstrated a significantly reduced decline in forced vital capacity compared to patients receiving placebo.
Ofev is an investigational small molecule tyrosine kinase inhibitor (TKI) that targets the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR). The safety and efficacy of Ofev was established in three clinical trials of patients with IPF (n=1,231). Compared to patients receiving placebo, those taking Ofev showed a significantly reduced level of decline in forced vital capacity.
RELATED: Inhaled Pirfenidone Designated Orphan Drug for IPF
Both Esbriet and Ofev were granted fast track, priority review, orphan product, and breakthrough designations by the FDA.
Esbriet will be available to patients with two weeks and Ofev will be available in nine days.
For more information on Ofev, call (800) 542-6257 or visit US.Boehringer-Ingelheim.com. For more information on Esbriet, call (800) 821-8590 or visit Gene.com.
