European Commission approves Roche’s new Esbriet tablet formulation for IPF


The European Commission (EC) has approved a new tablet formulation of Swiss pharmaceutical company Roche’s Esbriet (pirfenidone) to treat patients with mild to moderate idiopathic pulmonary fibrosis (IPF).

IPF is a fatal disease that causes irreversible, progressive scarring (fibrosis) of the lungs.

The condition makes breathing difficult and prevents the patient’s heart, muscles and vital organs from receiving enough oxygen to function properly.

Approved for the treatment of IPF, Esbriet is an oral medicine that slows down the progression of IPF.

The treatment is believed to interfere with the production of transforming growth factor (TGF)-beta, a small protein in the body that causes the cells to grow and produce scars (fibrosis), and tumour necrosis factor (TNF)-alpha, a small protein that is involved in inflammation.

"Being able to provide a tablet formulation of Esbriet gives patients more options for the management of their condition.”

Currently available in 801mg and 267mg tablets, Esbriet offers additional treatment options for IPF patients.

Roche global product development chief medical officer and head Dr Sandra Horning said: “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.”

Data has demonstrated that the use of Roche’s Esbriet tablets significantly help reduce the risk of death at 52 weeks by 48% in people with IPF compared with placebo.

The new tablet formulation has already been approved by the US Food and Drug Administration (FDA) and is currently available in the country.

On receiving the EC approval, the company expects to start launching the tablet formulation in several European markets throughout the year.


Image: A chest radiograph of a patient with Idiopathic Pulmonary Fibrosis. Photo: courtesy of IPFeditor via Wikipedia.