Roche’s Esbriet receives CHMP recommendation for label update

Roche has announced that a proposed label update for its drug Esbriet has received a positive opinion from Europe's Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has recommended the approval of a planned update to the idiopathic pulmonary fibrosis therapy's European prescribing information, which will help to strengthen its safety and efficacy profile.

New data that will be included on the label will reflect the findings of a pooled analysis of the clinical trial programmes ASCEND and CAPACITY, which showed the drug can deliver a 48 percent reduction in mortality risk at one year.

It also revealed that the risk of treatment-emergent disease-related mortality among Esbriet patients was reduced by 68 percent compared to placebo in the same timeframe.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "The inclusion of the Ascend data in the European prescribing label for Esbriet will provide important additional information for physicians and patients."

The company achieved a five percent year-on-year sales increase in the first three quarters of 2014, with the US approval of Esbriet contributing to this positive momentum.