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# FDA OKs Bayer’s Kovaltry for Hemophilia
- URL: https://www.fdaweb.com/fda-oks-bayers-kovaltry-for-hemophilia/
- Published: 2016-03-17T12:00:00.000Z
- Updated: 2026-09-15T02:45:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135118

> FDA has approved Bayer’s Kovaltry (antihemophilic factor-recombinant), a factor VIII compound for treating hemophilia A in children and adults. The approval is based on data from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which demonstrated the therapy’s supported safety and effectiveness for routine prophylaxis to reduce bleeding episode frequency, according to the company. During the trials, Kovaltry reduced bleeding episodes in patients with hemophilia A when infused twice to three times per week with routine prophylaxis, it says. The most frequently reported adverse reactions were headache, fever, and itchy rash.