Immediate-release formulation means fewer pills and more flexibility, says Roche

02-Jul-2017 - Last updated on 04-Jul-2017 at 13:41 GMT

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The European Medicines Agency has approved a new tablet formulation of Esbriet (pirfenidone), which Roche says reduces pill-load and increases dosing flexibility for patients with a rare lung disease.

The new, immediate-release formulation, designed for patients with mild to moderate idiopathic pulmonary fibrosis (IPF), is available in 801mg or 267mg tablet form.

Roche said the 801mg tablet can decrease the amount of pills taken daily, compared to the current capsule formulation.

“By changing the formulation into a tablet, we were able to reduce the pill burden for patients,” Roche spokesperson Anja von Treskow told us.

“Now patients can take one [801mg] tablet three times a day, instead of three capsules three times a day,” she said.

The 801mg tablet also offers patients a maintenance option by taking fewer pills per day, said Roche.

“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,” said chief medical officer Sandra Horning.

The 267mg tablet is film-coated and smaller than the bioequivalent 267mg capsule formulation, which Roche said may make the tablet version easier to swallow.

With regards to manufacturing technology, von Treskow told us “No additional investments in technologies were necessary and existing technologies within the Roche manufacturing network were able to be used.”

Roche did not disclose at which site the tablet is produced, however von Treskow did tell us Esbriet is produced within the in-house manufacturing network of Roche.

Esbriet (pirfenidone)

Orphan Drug Esbriet has been shown to slow the progression of IPF, a rare disease that causes irreversible, progression scarring (fibrosis) of the lungs.

Roche said although the exact effect Esbriet has on IPF patients is unclear, it believes the drug disturbs the proteins involved in inflammation.

“The mechanism of action of Esbriet is not fully understood, although it is believed to interfere with the production of transforming growth factor (TGF)-beta, a small protein in the body involved in the how cells grow and produce scars (fibrosis), and tumour necrosis factor (TNF)-alpha, a small protein that is involved in inflammation,” said the company.

Roche said it expects to launch the tablet formulation in a number of European markets before the end of the year.

The US Food and Drug Administration (FDA) approved the Esbriet tablet formulation in early 2017.