Pfizer receives EU approval for Vyndaqel

Pfizer has been granted European regulatory approval for Vyndaqel, its new therapy for transthyretin familial amyloid polyneuropathy (TTR-FAP).

The European Commission has ratified the new therapy for use among adult patients with stage 1 symptomatic polyneuropathy, based on positive data from a pivotal clinical trial and a subsequent open-label 12-month extension study.

It represents the first time that a treatment for TTR-FAP – a rare and fatal neurodegenerative disease affecting approximately 8,000 patients worldwide – has been approved in Europe.

Pfizer is now working with health authorities to launch the new therapy, which will be introduced across Europe in early 2012.

Yvonne Greenstreet, senior vice-president and head of the medicines development group for Pfizer's specialty care business unit, said: "Pfizer is focused on meeting the needs of patients suffering from rare diseases and this approval is an important step forward in our commitment to providing treatment options for patients."

Earlier this month, Pfizer reported positive new data from a clinical study of Toviaz, its treatment for overactive bladder.