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Hympavzi (marstacimab)

Region

🇪🇺 EU

Active substance

marstacimab

Company

Pfizer Europe MA EEIG

Status

Authorised

Therapeutic area

Hemophilia A; Hemophilia B

CHMP opinion

Thu 19 Sep 2024

EU approval

Mon 18 Nov 2024

Application

EMEA/H/C/006240

ATC

B02BX11

Official record

www.ema.europa.eu

Indication

Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with:&nbsp; Haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors who have severe disease (FVIII < 1%) with factor VIII inhibitors&nbsp; Haemophilia B (congenital factor IX deficiency) without factor IX inhibitors who have severe disease (FIX < 1%) with factor IX inhibitors.&nbsp;

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.