Roche withdraw application for Biojector needle-free option for T-20
2 October 2007. Related: Antiretrovirals.
On 3 October, Roche and Trimeris announced that they are withdrawing a supplement application for approval to market Biojector B2000 as a ‘needle-free’ option for delivery of T-20 (enfuvirtide). [1]
The reasons for not continuing with the applications was given as ‘based on comprehensive assessment of the clinical program, as well a significant delay in achieving U.S. regulatory approval due to the time required to generate additional data’.
It has been over three years since the first studies showing similar pharmacokinetics and the potential for better tolerability using Biojector compared to regular injections. [2, 3] Safety concerns in larger studies included an increased risk of nerve damage and haematoma.
Patients in the UK are not able to access Biojector as the manufacturer does not have a European license for this device.
Patients currently using Biojector in the US through an expanded safety trial may be able to continue to use the device, as it is still commercially available there.
References:
- Press release: Roche and Trimeris provide update on development of alternative administration options for delivery of FUZEON: Companies withdraw application to market Biojector® 2000 device for use with Fuzeon. (03.10.07)
http://www.roche.com - Needle-free injections for T-20 in the US. HIV Treatment Bulletin, April 2005.
http://www.i-base.info/htb/v6/htb6-4/Needle.html - T-20 studies presented at Rio. HIV Treatment Bulletin, September 2005.
http://www.i-base.info/htb/v6/htb6-9/T20.html