Kishanlal Munshi: EC Approves Pfizer’s HYMPAVZI for Hemophilia A and B With Inhibitors
Kishanlal Munshi, Vice President-Technical at Sarabhai Group, shared a post on LinkedIn:
“European Commission Approves Pfizer’s HYMPAVZI for the Treatment of Adults and Adolescents with Hemophilia A or B With Inhibitors:
Pfizer Inc. today announced that the European Commission (EC) has granted marketing authorization to expand the approved indication for HYMPAVZI (marstacimab) to include patients 12 years of age and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors.
HYMPAVZI offers a combination of superior bleed protection compared to on-demand (OD) treatment that is well-tolerated with a straightforward, once-weekly subcutaneous injection administration that does not require routine treatment-related lab monitoring for this difficult-to-treat inhibitor patient population 12 years of age and older.
Inhibitors limit treatment options for people living with hemophilia and are associated with an increased risk of uncontrolled bleeding. These inhibitory antibodies neutralize factor replacement therapies and render them ineffective.
Of the more than 800,000 people in the world living with hemophilia A or hemophilia B, approximately 20% of those with hemophilia A and 3% of those with hemophilia B are unable to continue taking factor replacement therapies because they developed inhibitors to FVIII and FIX, respectively, and these therapies no longer prevent or stop bleeding episodes, particularly in individuals who are refractory to immune tolerance induction therapy.
The approval of HYMPAVZI offers adults and adolescents in the EU a once-weekly subcutaneous option that has demonstrated the ability to reduce bleeding episodes and maintain bleed reduction based on observation to date in a long-term extension study.”
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