FDA approves Merck’s HIV fat drug Egrifta
pharmafile | November 12, 2010 | News story | Research and Development, Sales and Marketing | EMD Serono, Egrifta, FDA, HIV, Merck KGaA, abdominal fat in HIV, tesamorelin
US regulatory authorities have approved the first treatment indicated to target abdominal fat in patients with HIV after trials showed it reduced waist circumference.
The FDA has given the nod to Merck KgaA’s Egrifta (tesamorelin for injection) to treat HIV-infected patients with lipodystrophy (abdominal lipohypertrophy) – a metabolic complication associated with HIV.
Egrifta’s limitations are considerable, however. For example, there is as yet no understanding of the drug’s cardiovascular safety or benefit.
There is also no data to support improved compliance with antiretroviral therapies in HIV-positive patients taking the drug, which was developed by Canadian biopharma firm Theratechnologies.
As part of the approval, the FDA now wants a long-term observational safety study for tesamorelin acetate (Egrifta), a single vial formulation, as well as a new presentation of the same formulation.
It also wants Merck to carry out a clinical trial to assess whether Egrifta impacts on diabetic retinopathy in diabetic HIV-infected patients with lipodystrophy and excess abdominal fat.
“While antiretroviral therapy is extremely important in the management of patients with HIV infection, some patients are experiencing excess abdominal fat associated with lipodystrophy, which can be difficult to manage,” said Fereydoun Firouz, chief executive of EMD Serono, the Merck affiliate which will market the drug in the US.
FDA approval was based on two randomised, double-blind, placebo-controlled phase III trials looking at decreases in visceral adipose tissue (VAT) and waist circumference (WC).
In the first, patients on Egrifta saw a WC decrease of -3 cm compared to a decrease of -1 cm with placebo. The second trial saw a reduction in WC of -2 cm compared to a decrease of -1 cm.
These decreases, observed after 26 weeks of treatment, were sustained in patients who received Egrifta over 52 weeks.
The primary endpoint of the 26-week main phase was the change in VAT, as assessed by computed tomography (CT) scan at the L4-L5 vertebral level.
Patients treated in the first study with Egrifta saw a statistically significant mean decrease from baseline in VAT of 27 cm2 compared to an increase of 4 cm2 for patients on placebo.
In the second, VAT was reduced by 21 cm2 compared to no change for patients on placebo.
Adam Hill
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