The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic version of Pfizer’s Vyndaqel (tafamidis meglumine), marking it as the first generic to pass the generic quality consistency evaluation (GQCE) in China. This development is highlighted on the NMPA’s official website.
Tafamidis meglumine is indicated for the treatment of adult patients exhibiting phase I symptoms of transthyretin amyloid polyneuropathy (ATTR-PN), a rare genetic disorder that is progressive and often fatal. The condition typically manifests between the ages of 30 and 40 and is characterized by irreversible nerve damage. ATTR-PN primarily affects the peripheral nervous system, with symptoms that start in the extremities and progress towards the body, involving motor, sensory, and autonomic nerves. It can also cause damage to other organs such as the heart, kidneys, and eyes. Tafamidis meglumine works by stabilizing transthyretin protein (TTR), thereby slowing the dissociation of TTR into monomers and delaying the production and deposition of ATTR amyloidosis, which is crucial for its therapeutic efficacy.- Flcube.com
