Investigational fertility treatment approved by FDA

September 12, 2013

The US Food and Drug Administration approved the new drug application (NDA) for Merck’s investigational fertility treatment corifollitropin alfa. Merck is seeking approval for the use of corifollitropin alfa in controlled ovarian stimulation (COS). If approved, the drug would be the first sustained follicular stimulant available in the United States.

 

The US Food and Drug Administration approved the new drug application (NDA) for Merck’s investigational fertility treatment corifollitropin alfa. Merck is seeking approval for the use of corifollitropin alfa in controlled ovarian stimulation (COS). If approved, the drug would be the first sustained follicular stimulant available in the United States.

In a phase III study of the drug, 1390 women aged 35–42 years were treated at 33 IVF centers across the United States. The primary efficacy point was the vital pregnancy rate, measured by the presence of at least 1 fetus registering heart activity at least 35 days after an embryo transfer. A second efficacy endpoint looked at ongoing pregnancy rates, measured by either continued fetal heart activity roughly 10 weeks after transfer or a live birth.

During the first 7 days of COS, 694 women received 1 injection of 150 mcg of corifollitropin alfa and 696 women received 7 daily injections of 300 IU recombinant follicle stimulating hormone (rFSH). The vital pregnancy rate was comparable between corifollitropin alfa treatment and rFSH (n = 166, 23.9% vs n = 187, 26.9%). Comparable rates were seen for the second efficacy endpoint: 22.2% for corifollitropin alfa and 24.0% for rFSH.

Drug-related adverse events were seen in 20.5% of women treated with corifollitropin alfa and 18.5% for rFSH. The most common side effects were headache, pelvic discomfort, nausea, breast tenderness, fatigue, pelvic pain, injection site pain, and dizziness.

Corifollitropin alfa is approved in more than 50 markets outside of the United States, including in the European Union.

 

 

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