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FDA approves first drug for lipodystrophy

The US Food and Drug Administration has approved Egrifta as the first treatment for HIV patients with lipodystrophy

The US Food and Drug Administration (FDA) has approved Egrifta (tesamorelin) as the first treatment for HIV patients with lipodystrophy, a condition in which excess fat develops around the liver, stomach, and other abdominal organs, as well as in other places in the body.

Egrifta was developed by the Canadian company Theratechnologies and will be marketed in the US by EMD Serono, an affiliate of Germany's Merck KGaA. The product is a growth hormone releasing factor drug that is administered as a once-daily injection.

Lipodystrophy, which is associated with many antiretroviral drugs used to treat HIV, can contribute to other health problems as well as negatively affect quality of life, the FDA noted. The clinical studies conducted by Theratechnologies did not evaluate whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs.

The placebo-controlled studies submitted to the FDA by the company involved a total of 816 HIV-infected adults with lipodystrophy and excess abdominal fat. The studies showed that patients treated with Egrifta experienced greater reductions in abdominal fat as measured by CT scan than were experienced by patients given a placebo injection.

EMD Serono acquired the US rights to the drug in late 2008, while the product was in phase III, under a deal that could be worth up to $215m to Theratechnologies. Under the agreement, Theratechnologies received an upfront payment of $30m, including a licence fee of $22m and an equity investment of $8m by Merck KGaA. The Canadian company is also entitled to development, regulatory and sales milestones, as well as increasing royalties on annual net sales of tesamorelin in the US.

EMD Serono also has an option to participate in future indications in the US, with Theratechnologies maintaining the right, subject to EMD Serono's agreement, to co-promote the additional uses. Egrifta has therapeutic potential in a variety of anabolic and lipolytic indications, according to the companies.

12th November 2010

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