Pfizer’s Vyndaqel (tafamidis, 61mg) Receives EC’s Approval as the First Therapy to Treat Transthyretin Amyloid Cardiomyopathy in the EU

Pfizer’s Vyndaqel (tafamidis, 61mg) Receives EC’s Approval as the First Therapy to Treat Transthyretin Amyloid Cardiomyopathy in the EU

Shots:

  • The EC approval is based on P-III ATTR-ACT study assessing Vyndaqel (tafamidis meglumine, 20/80mg) vs PBO in patients with ATTR-CM that demonstrated a reduction in mortality and frequency of cardiovascular-related hospitalizations @30mos. (30% vs 32%) and is well tolerated
  • The approval is also based on findings from an evaluation of the free acid form of tafamidis (61mg) that demonstrated that tafamidis (61mg) free acid corresponds to tafamidis meglumine (80mg dose)
  • Vyndaqel (tafamidis, 61mg) & Vyndaqel (tafamidis meglumine, 20 mg) are oral transthyretin stabilizers, stabilizing the tetramer of the transthyretin transport protein and slowing the formation of amyloid and is the first therapy to treat ATTR-CM and stage 1 ATTR-PN in the EU

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: Clinical Trial Arena