Pfizer’s Vyndaqel achieves new regulatory milestone in US

Pfizer has announced that Vyndaqel, its treatment for transthyretin familial amyloid polyneuropathy (TTR-FAP), has reached a key milestone in its US regulatory review process.

The US Food and Drug Administration (FDA) has accepted the company's new drug application for the tafamidis meglumine therapy, which has already been approved in Europe, and given it a priority review designation.

An anticipated Prescription Drug User Fee Act action date has been set for June 2012, with the FDA believing the compound can offer potentially significant benefits to an underserved patient community.

TTR-FAP is a rare and fatal neurodegenerative disease caused by a genetic mutation of the TTR gene, taking effect as early as the 30s before progressing to the terminal stage within ten years on average.

It was approved in November 2011 by the European Commission for use in the treatment of TTR amyloidosis in adult patients with stage 1 symptomatic polyneuropathy.

Last month, Pfizer announced a 2011 revenue total of $67.43 billion (43 billion pounds), up by one percent compared to the year before.