When was egrifta approval

Egrifta works by binding and stimulating human growth hormone-releasing factor GRF receptors with similar potency as the endogenous GRF in vitro. Growth hormone exerts its effects by interacting with specific receptors on a variety of target cells, including chondrocytes, osteoblasts, myocytes, hepatocytes, and adipocytes, resulting in a host of pharmacodynamic effects.

For more information call or visit Egrifta. Furthermore, it is stable at room temperature, thus it does not require a cold-chain distribution network from the manufacture to the patient. This represents an advantage for patients as well as for Theratechnologies. Full prescribing information available at www. The primary efficacy assessment for each of these studies was the percent change from baseline to Week 26 Main Phase in visceral adipose tissue cm2 , as assessed by computed tomography CT scan at L4-L5 vertebral level.

In both studies, Egrifta- treated patients completing the week treatment period were re-randomized to blinded therapy with either daily placebo or 2 mg Egrifta for an additional week treatment period Extension Phase in order to assess maintenance of VAT reduction and to gather long-term safety data. Study One Main Phase This study randomized subjects. At Week 26, treatment with Egrifta resulted in a reduction from baseline in mean trunk fat of 1.

In addition, Egrifta resulted in an increase from baseline in mean lean body mass of 1. Extension Phase This study re-randomized subjects. Those treated with Egrifta showed no change between Weeks 26 and 52 in mean trunk fat increase of 0.

Study Two Main Phase This study randomized subjects. Full Approval. Download PDF. Share This Article. We use cookies on this website. By using this site, you agree that we may store and access cookies on your device.

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