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FDA priority review for Roche’s Esbriet in unclassifiable interstitial lung disease

Agency is due to make a decision for the approval by May 2021

Roche has announced that the US Food and Drug Administration (FDA) has accepted its blockbuster idiopathic pulmonary fibrosis (IPF) drug Esbriet for priority review in a new indication.

Roche’s Genentech division is seeking approval for Esbriet (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD).

Interstitial lung disease (ILD) encompasses a diverse group of over 200 types of rare pulmonary diseases. UILD is attributed to cases where a definitive diagnosis, even after a through investigation, is not reached.

The supplemental New Drug Application (sNDA) is based on results from a phase 2 study which demonstrated that UILD patients treated with Esbriet had significantly more stable lung function compared to placebo.

“Since its US approval, Esbriet has become a standard of care for people living with idiopathic pulmonary fibrosis,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche.

“However, significant unmet need remains in fibrotic lung diseases, including UILD. We are working closely with the FDA in the hopes of offering Esbriet to people with UILD, a rare and debilitating disease,” he added.

The FDA is due to make a decision for the approval of Esbriet in UILD by May 2021.

Esbriet was one of the drugs that were part of Roche's $8.3bn takeover of InterMune in August 2014 – at the time, Esbriet was already on the market in the EU and Canada. Shortly afterwards, in October 2014, the drug won an approval in IPF from the FDA.

Although Esbriet brings in annual sales topping $1bn, Roche is hoping to extend its reach beyond IPF as it stands to face expirations on some patent protections covering the drug this year.

The Swiss pharma company already has an ongoing patent lawsuit against a number of generic drugmakers, including Novartis’ Sandoz division and Teva Pharmaceuticals, which are seeking to bring cheaper, generic versions to the market.

Another major IPF drug and Esbriet’s main rival – Boehringer Ingelheim’s Ofev (nintedanib) – picked up an FDA approval for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in September 2019.

Ofev is a tyrosine kinase inhibitor (TKI) that targets several growth factors involved in IPF – the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and the platelet-derived growth factor receptor (PDGFR).

Esbriet blocks the synthesis of TGF-beta, a chemical that controls many cell functions and plays a key role in fibrosis.

Article by
Lucy Parsons

22nd January 2021

From: Regulatory



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