AOP Orphan, a pioneering pharmaceutical company in the field of rare diseases, is launching in Europe the world's first drug approved by the FDA that can be used effectively against lipodystrophy (excess abdominal fat), which is widespread among HIV patients: EGRIFTA®.
It has been possible to bring HIV under control in recent years with the use of antiretroviral drugs, and many HIV-positive people live much longer than they used to. However, many patients develop complex metabolic changes in the course of essential treatment with HIV drugs, which can lead to a marked increase in visceral abdominal fat (lipohyertrophy) and cardiovascular diseases, as well as favoring myocardial ischemia. The quality of life among HIV patients is also often negatively impacted by these physical changes. With EGRIFTA®, physicians now have a way of treating suitable patients (on a case-by-case basis) that demonstrable reduces this excess abdominal fat.
Tesamorelin, which is already available on the Canadian and US markets under the trademark EGRIFTA® as a subcutaneous injection, is a synthetic form of growth-hormone-releasing hormone (GHRH). It stimulates the release of the body's own growth hormone and helps to reduce the amount of fat around the liver, stomach and other abdominal organs. Furthermore, it can have a positive effect on lipid levels and lower cardiovascular disease risks.
The effectiveness of EGRIFTA® was evaluated in two separate, randomized and placebo-controlled phase III studies with 806 HIV-infected men and women afflicted by lipodystrophy (1). The patients were either given EGRIFTA® or a placebo over the course of 26 weeks. After this phase of the treatment, patients who had been given EGRIFTA® saw an 18 % (first study) and 14 % (second study) reduction in visceral fat, whereas only a 2 % increase or decrease in fat levels was observed in the control group. Tesamorelin (EGRIFTA®) is injected daily and to be used permanently.
EGRIFTA® has been approved by the US Food and Drug Administration (FDA) as well as by Health Canada and is an effective way of treating lipodystrophy in HIV patients. AOP Orphan now intends to make it available on the European market and, to this end, it has concluded an agreement with the Canadian company that developed EGRIFTA®, Theratechnologies Inc., for a number of European countries. AOP Orphan will contribute its expertise in the field of regulatory affairs to obtain further approvals in the defined markets. Until then, EGRIFTA® is only available as part of so-called named patient programs, i.e. for individual patients at the request of a physician. These countries are: Albania, Austria, Belarus, Belgium, Bosnia, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia, the Netherlands, Norway, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, Sweden, Switzerland, Ukraine and the UK. Theratechnologies Inc. is responsible for production.