FDA decision delayed on Biojector for administering T-20 pending additional safety information
Simon Collins, HIV i-Base
On 12 October, Roche issued a press release relating to the timeline for the FDA decision on the Biojector 2000 system that is currently being studied in an open label expanded access trial in the US.
Several small studied reported that many patients found this needle-free device, which fires T-20 through the skin under pressure, reduced the severity of injection site reactions, and improved quality of life.
In the larger safety study, a small proportion of patients have experienced haemotoma and nerve damage, largely relating to when the device has been used in site with earlier scar tissue or near bone – both of which are not recommended as injection sites in the prescribing information for T-20.
Collecting additional data on these events will probably delay the FDA decision until early 2007.
It is expected that this will have a similar effect on regulatory decisions in Europe. Currently, unless they have been able to purchase this privately in the US, UK patients do not have access to the Biojector.
Source: Roche press release (12 October, 2006)