Roche’s new tablet for fatal lung disease cleared in EU

Roche’s new tablet for treating certain types of idiopathic pulmonary fibrosis (IPF) was approved by the European Commission, the Swiss drugmaker announced on Tuesday.

The new tablet formulation approval of Esbriet (pirfenidone) was approved for the treatment of mild to moderate IPF, a fatal condition that causes irreversible, progressive scarring of the lungs.

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.”