New Single-Vial Formulation of Tesamorelin Approved to Treat Excess HIV-Related VAT

HIV infection
HIV infection
The new "F4" formulation is 4 times more concentrated than the version currently available on the market.

Theratechnologies announced that the Food and Drug Administration (FDA) has approved Egrifta (tesamorelin for injection) in a new single-vial formulation. 

Egrifta, a growth hormone-releasing factor analog, is currently approved to treat excess abdominal visceral adipose tissue (VAT) in HIV-infected patients with lipodystrophy. It was originally supplied as a 2mg per vial powder for subcutaneous (SC) injection after reconstitution in a 2-vial formulation. 

The new “F4” formulation is also intended for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. It is 4 times more concentrated than the version currently available on the market, allowing for a smaller volume of administration (0.35mL) vs that required for the current formulation (2.0mL). Also, it is stable at room temperature and thus does not require a cold-chain distribution network from the manufacturer to the patient. 

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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. 

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This article originally appeared on MPR