European Commission approves Roche's Esbriet tablet for mild to moderate IPF treatment

Esbriet has been shown to slow the progression of IPF 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.

“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. 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. 

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.

Esbriet is an oral medicine approved for the treatment of IPF and is available in more than 40 countries worldwide. The mechanism of action of Esbriet is not fully understood, although it is believed to interfere with the production of transforming growth factor (TGF)-beta, a small protein in the body involved in how cells grow and produce scars (fibrosis), and tumour necrosis factor (TNF)-alpha, a small protein that is involved in inflammation.

Esbriet has Orphan Drug designation and was approved for use in Europe in 2011 in adults with mild-to-moderate IPF16 and in the US in people with IPF in October 2014.17In early 2017, the US Food and Drug Administration (FDA) approved the Esbriet 801 mg and 267 mg tablets as new options for administering the medicine for the treatment of IPF. The new 801 mg tablets, which are now available in the US, offer people with IPF a maintenance option for taking Esbriet with fewer pills per day.

Esbriet is approved in Europe for the treatment of IPF on the basis of four Phase 3, multicentre, randomised, double-blind, placebo-controlled studies in patients with IPF. Three of the phase 3 studies (ASCEND and CAPACITY 004 and 006) were multinational, and one (SP3) was conducted in Japan. Esbriet has a well-established safety profile, the most common adverse events being related to the gastrointestinal tract (nausea, diarrhoea, dyspepsia), skin (rash and photosensitivity reaction), as well as fatigue and anorexia.

European commission, roche's esbriet tablet, moderate ipf treatment