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- 06/28/2017

Fewer pills, more flexibility in dosing: Roche’s new Esbriet tablet formulation approved in Europe for mild to moderate idiopathic pulmonary fibrosis (IPF

Pharma Horizon
  • New immediate-release tablet formulation of Esbriet offers a reduced pill burden for patients with idiopathic pulmonary fibrosis (IPF)
  • People with IPF now have the option of taking one Esbriet tablet three times per day, instead of three capsules three times per day
  • IPF is a rare, incurable lung disease. On average, patients live two to five years following an IPF diagnosis1

Roche announced that the European Commission (EC) has approved a new tablet formulation of Esbriet® (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a fatal condition that causes irreversible, progressive scarring of the lungs.2

Esbriet has been shown to slow the progression of IPF,3,4 and the new tablet formulation, available as an 801 mg or 267 mg tablet, is designed to provide additional treatment options for people living with the disease.

The new 801 mg tablet can reduce the pill burden; patients can take one tablet three times per day instead of three capsules three times per day. The film-coated 267 mg tablet that has been introduced is smaller than the 267 mg capsule and might be easier to swallow. At equal doses, the new tablet formulation is bioequivalent to the currently available capsule version of Esbriet.5

“We are pleased to launch this important new formulation for people living with IPF, as part of our mission to improve the lives of patients with this devastating disease,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are committed to helping people living with IPF, and being able to provide a tablet formulation of Esbriet gives patients more options for the management of their condition.”   

IPF is a devastating and poorly understood condition that requires treatment as early as possible to help people with the disease maintain independence and live longer, better lives.6 Data have shown that treatment with Esbriet significantly reduced the risk of death at 52 weeks by 48% in people with IPF compared with placebo (p=0.01).7 At Week 52, a decline from Baseline in percent predicted FVC of ≥10% or death was seen in 17% of patients receiving Esbriet compared to 32% receiving placebo.8 Furthermore, Esbriet significantly reduced the decline in 6-minute-walk test distance, a measure of functional disease status, by 44.2% compared to placebo. 7

The new Esbriet tablet formulation is already approved by the United Stated (US) Food and Drug Administration (FDA) and available in the US. Following this EC approval, Roche expects to begin launching the tablet formulation in a number of European markets throughout 2017.

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