European Commission Approves New Esbriet Tablet for IPF Treatment

The European Commission (EC) recently approved a new formulation of Esbriet (pirfenidone) tablets for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). According to Roche, Esbriet’s developer, the new tablet formulation will reduce the number of pills patients need to take throughout the day, offering patients an easier treatment option.

Roche plans to launch the new tablets in several European countries throughout 2017. The tablets, which come in a 801 mg and a 267 mg formulation, were approved by the U.S. Food and Drug Administration (FDA) in early 2017, and are already available in the U.S.

Earlier Esbriet formulations require some patients to take three capsules three times per day. The new 801 mg instant release tablet achieves the same drug concentration as the three capsules, but patients only need to take one tablet three times a day. With this alternative, Roche hopes to provide IPF patients with a new option for maintenance treatment with Esbriet involving fewer pills per day.

Roche also reported that the new 267 mg tablet is smaller than the earlier 267 mg capsule, which might make it easier to swallow.

“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,” Sandra Horning, MD, Roche’s chief medical officer and head of global product development, said in a press release.

Studies have shown that Esbriet reduces disease progression, with a slower decline of lung function and in exercise capacity. The treatment also reduces rates of respiratory hospitalizations, and allows IPF patients to live for longer, reducing the risk of death by 48 percent in one of the clinical trials, compared to placebo treatment. This makes Esbriet a crucial treatment for a disease that typically causes the death of half of IPF patients within three years following a diagnosis.

“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.” Horning said.

Researchers also believe that current research into how Esbriet prevents disease progression in people with lung fibrosis may lead to the development of even better antifibrotic treatments in the future.