Ofev (Nintedanib) Facts
- Nintedanib is an orally bioavailable, small-molecule tyrosine kinase inhibitor (TKI) developed for the treatment of IPF and SSc-ILD. Both these conditions share similarities in terms of the formation of lung scarring or fibrosis.
- Nintedanib targets growth factor receptors, which have been shown to be involved in the mechanisms by which pulmonary fibrosis occurs. It competitively inhibits both non-receptor tyrosine kinases (nRTKs) and receptor tyrosine kinases (RTKs).
- In August 2016, nintedanib gained Orphan drug Designation from European Commission to treat systemic sclerosis.
- In September 2016, the FDA granted Orphan Drug Designation to nintedanib for the treatment of systemic sclerosis (SSc), including associated interstitial lung disease (SSc-ILD).
- In March 2018, the FDA granted Fast Track designation to Boehringer Ingelheim’s nintedanib for the treatment of Systemic Sclerosis with associated Interstitial Lung Disease (SSc-ILD). The designation is based on the Investigational New Drug Application for SSc-ILD and the anticipated efficacy and safety data from the phase III SENSCIS trial.
- In October 2019, the FDA has granted Breakthrough Therapy designation to nintedanib for the treatment of chronic fibrosing ILDs with a progressive phenotype. The designation is supported by data from the 52-week, double-blind, placebo-controlled, phase 3 INBUILD trial that evaluated the efficacy and safety of nintedanib in 663 patients with PF-ILD.
- As per Delveinsight analysis, this drug is a blockbuster and is expected to generate a noteworthy revenue of more than USD 2 billion for the treatment of Progressive-fibrosing interstitial lung disease (PF-ILD) in the near future after the successful launch in the market.
Ofev (Nintedanib) Approval History
- In September 2019, Nintedanib was approved under the brand name Ofev by the United States Food and Drug Administration (FDA) for the treatment of Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD).
- In March 2020, The U.S. Food and Drug Administration approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.
- In April 2020, the European Commission approved Ofev (nintedanib) to preserve lung function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
- In July 2020, the European Commission approved Ofev (nintedanib) for the treatment of progressive fibrosing interstitial lung diseases (ILDs) in adults.
- It has previously been approved for the treatment of Idiopathic Pulmonary Fibrosis (IPF) in the US, EU, and Japan.
Key abstracts/Posters
Poster Board Number: P604; Session Number A37
Abstract Number: A1525: Title – Effect of Nintedanib in Patients with Limited and Extensive Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Data from the SENSCIS Trial
Conclusions:
- In the SENSCIS trial in subjects with SSC-ILD, the rate of decline in FVC in the placebo group was numerically greater in subjects with an extent of fibrotic ILD on HRCT ≥30% than ≤30% and with FVC ≤70% than ≥70% predicted at baseline.
- Our findings suggest that nintedanib reduced the rate of decline in FVC both in subjects with extensive ILD and limited ILD at baseline.
Poster Board Number: 709; Session Number C22
Abstract Number: A4555: Title – Effect of Nintedanib in Patients with Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analyses from the INBUILD Trial
Conclusions: In the INBUILD trial, nintedanib had a consistent effect on reducing the annual rate of decline in FVC in patients with progressing fibrosing ILDs, irrespective of demographic characteristics lung function, or ILD diagnosis at baseline.
Roche demonstrated data for its Esbriet (Pirfenidone) in Unclassifiable Interstitial Lung Disease
F. Hoffmann-La Roche Ltd is worth mentioning here, as they are presenting key posters and studies on Pirfenidone in Unclassifiable Interstitial Lung Disease (uILD).
Esbriet (Pirfenidone) Facts
- Pirfenidone is an orally active small molecule drug that may inhibit collagen synthesis, down-regulate production of multiple cytokines, and block fibroblast proliferation and stimulation in response to cytokines.
- The molecule has demonstrated activity in multiple fibrotic conditions, including those of the lung, kidney, and liver. Pirfenidone inhibits fibroblast, epidermal, platelet-derived, and transforming beta-1 growth factors, thereby slowing tumor cell proliferation
- The drug also inhibits DNA synthesis and the production of mRNA for collagen types I and III, resulting in a reduction in radiation-induced fibrosis.
- In August 2014, Roche acquired InterMune for USD 8.3 billion. The acquisition gives Roche ownership of the IPF drug Esbriet (pirfenidone).
- Hoffmann-La Roche holds a patent with patent number 10,188,637; for the granulate formulation of pirfenidone and its method of making, which is expected to expire in 2037. Intermune, Inc. a division of Roche holds various patents regarding administration, treatment, and formulations of pirfenidone.
Poster Board Number: 711; Session Number C22
Abstract Number: A4557: Title – Pirfenidone in Unclassifiable Interstitial Lung Disease (uILD): A Subgroup Analysis Stratified by Concomitant Mycophenolate Mofetil (MMF) Use
Significance: Pirfenidone might have a differential effect on FVC change in patients with uILD depending on baseline concomitant MMF treatment status-further research is required
