A US Food and Drug Administration advisory panel has requested additional data for a needle-free version of Roche’s top-selling anti-HIV drug, Fuzeon (enfuvirtide). The approvable letter requests more information from the ongoing WAND study, an open-label trial evaluating the tolerability of the device.
The B2000, developed by Bioject Medical Technologies, uses carbon dioxide to power liquid medication through the skin. Roche and partner Trimeris first sought marketing clearance to use the device alongside its anti-HIV drug in May this year, and in August initiated the WAND study – an eight-week trial designed to assess patient acceptance and experience of the device versus a standard needle.
The trial is still enrolling, and final data are expected in the second half of next year, which could push back a US nod significantly. However, shares in Bioject rose 8.5% on the Nasdaq stock exchange yesterday as investors reacted positively to the news of an approvable letter, suggesting full clearance may not be that far off.