Shire’s antihemophilic Adynovate trails Bayer’s Kovaltry into Latin America



GBI analysis shows that Takeda subsidiary Shire’s Adynovate (rurioctocog alfa pegol) this week obtained market clearance from Brazil’s National Health Surveillance Agency (ANVISA). While the agency has not yet published indication details, the injectable drug is used to treat patients with hemophilia A (congenital factor VIII deficiency).

Adynovate is a PEGylated form of a recombinant full-length human coagulation factor VIII designed to temporarily replace the missing clotting factor VIII that is needed for effective hemostasis. Its PEGylation reduces binding to the physiological factor VIII clearance receptor (LRP1), thus extending Adynovate’s half-life compared to parent molecule Advate (octocog alfa), marketed by Takeda.

According to GBI analysis, ANVISA’s is the first regulatory approval that Adynovate obtains in Latin America, although Advate is present in the markets of Argentina, Brazil, Chile, Colombia, Ecuador, and Mexico. Adynovate’s registration comes only one week after the approval of competitor Bayer’s Kovaltry (octocog beta) in Brazil, which also marked its entrance into the region.

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