FDA panel recommends approval of New-Fill
2 May 2004. Related: Side effects, Lipodystrophy and metabolic complications.
Simon Collins, HIV i-Base
On 25 March, the US Food and Drug Administration (FDA) convened a panel to review study results for accelerated approval of New-Fill (Sculptra). The studies that were reviewed included the early Vega Study from Paris and the study from the Chelsea and Westminster Hospital in London.
New-Fill is now owned by Aventis/Dermik. The meeting also included public testimony from patients on how lipoatrophy made it difficult to lead a normal life and that treatment had changed their personal and professional lives.
New-Fill is already used in the UK to repair HIV-related facial lipoatrophy, but until National Health Service programmes are established, access has been largely limited to patients who can pay privately for this treatment. Approval in the US is likely to encourage NHS acceptance of this treatment.
The FDA panel voted 9-0 to recommend that FDA grant conditional approval for correction of facial shape and contour deficiencies resulting from facial fat loss associated with HAART for HIV. This does not mean that New-Fill has been approved but it is very unusual for a panel recommendation not to be followed. As conditions of approval, the panel recommended FDA require a two to five year post market study. Further research should attempt to establish differences, if any, of New-Fill therapy on women, minorities and patients with normal immune systems. The panel also urged FDA to go beyond strong labeling warnings to prevent New-Fill from being used off label for non-HIV patients.
Significant weight was given to the personal testimonies at the meeting.
Data slide presentation: