CHMP Backs Roche's IPF Drug Esbriet Label Update

Roche reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending the label update of its Esbriet (pirfenidone) in the EU.

Esbriet is an oral drug approved in the EU as a treatment for mild to moderate idiopathic pulmonary fibrosis (IPF), an irreversible and fatal lung disease characterized by lung tissue scarring and a decline of lung function — an illness that affects an estimated 110,000 people in the EU. Pirfenidone is believed to interfere with the production of Transforming Growth Factor (TGF)-beta and Tumor Necrosis Factor (TNF)-alpha, small proteins implicated in fibrosis and inflammation respectively. The drug has been awarded Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation in both the EU and the U.S.

The CHMP recommends the inclusion of data from the Phase 3 study ASCEND, which shows that pirfenidone significantly reduced forced vital capacity (FVC) in patients compared to placebo at one year. FVC is a measure that indicates the risk of mortality in patients with IPF. Combined analyses data from ASCEND and two Phase 3 CAPACITY trials show a 48 percent reduction in mortality risk at 12 months compared with placebo. In addition, a 68 percent reduction in risk of treatment-emergent IPF-related mortality was observed in favor of the Esbriet group compared to placebo at one year.

“This recommendation from the CHMP acknowledges the compelling evidence for Esbriet to reduce the progression of this deadly disease in people with IPF. The inclusion of the ASCEND data in the European prescribing label for Esbriet will provide important additional information for physicians and patients,” said Sandra Horning, Chief Medical Officer and Head of Global Product Development at Roche.

Jonathan Leff, EVP of R&D at Roche company InterMune, said, “This label amendment reinforces Esbriet’s role as an important treatment option for patients with IPF.”

The label update of Esbriet will take effect in the EU, allowing prescription information to be updated following this positive recommendation from the CHMP.