Posted by Michael Wonder on 13 Dec 2019
Pfizer receives positive CHMP opinion for Vyndaqel for use in patients with transthyretin amyloid cardiomyopathy, a rare and fatal disease
13 December 2019 - If approved by the European Commission, Vyndaqel will be the first pharmacologic therapy in the EU for patients with transthyretin amyloid cardiomyopathy.
Pfizer announced today that the CHMP of the EMA has adopted a positive opinion recommending the approval of Vyndaqel (tafamidis), a once-daily 61 mg oral capsule, for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
In 2011, a different form of Vyndaqel, tafamidis meglumine 20 mg capsule, was approved in the EU for transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy (ATTR-PN) to delay peripheral neurologic impairment. For ATTR-CM, the tafamidis 61 mg capsule corresponds to an 80 mg tafamidis meglumine dose (4 x 20 mg capsules) and was developed for patient convenience to enable a single capsule for daily administration.
