Drug company Roche has withdrawn its application to US regulatory authorities for approval of a needle-free way of administering their fusion inhibitor T-20 (enfuvirtide, Fuzeon).
T-20 is the only antiretroviral drug that needs to be injected. It has a relatively benign side-effects profile, but twice-daily injecting of the drug leads to the development of injection site reactions in 98% of patients.
Clinical trials had shown that the Biojector 2000 (B2000) was a generally safe and acceptable method of T-20 administration. Rather than using needles, the B2000 uses high pressure to force T-20 below the skin. Although the B2000 reduced the incidence of injection site reactions in T-20-treated patients, earlier this year the Food and Drug Administration, which regulates medicines in the US, updated the product labelling for the B2000 after it was found to cause long-lasting nerve pain in some patients.
Roche have now announced that they will not be pursuing their application for US approval for the B2000 for T-20 administration. In a press release they cite: “significant delay in achieving US regulatory approval due to the time required to generate additional data.”
Patients in the US who are currently using the B2000 to administer T-20, either because of their inclusion in a clinical trial or other programme, will be allowed to continue to use the B2000 to take the drug.
“While the [B2000] has shown potential benefit for some patients, we don’t believe it’s the ideal alternative delivery option for all treatment-experienced patients”, said Roche Vice-President for HIV, Michelle Zupancic. She added that the company will “continue to review other options for administering Fuzeon. In addition, we continue to offer Nurse Connections, a free support program that provides patients in the US with personalised, in-home instruction from a highly-trained nurse.”