Becton Dickinson is staring down the barrel of another FDA rejection for Lutonix, a catheter-mounted balloon coated with the antiproliferative paclitaxel, after an adcom vote yesterday went heavily against the device’s proposed use in below-the-knee critical limb ischaemia. The panel voted 15-2, with one abstention, that the balloon was safe – but the proportions were reversed on the efficacy vote. The vote on whether Lutonix’s benefits outweigh its risks went 14-3 against, again with an abstention. The pivotal trial in this indication had been subject to protocol redesigns and was stopped early by Becton in 2018 before reaching its initial enrolment target. Ultimately it hit on safety but not on efficacy, showing a non-significant 10.5% improvement over angioplasty with an uncoated balloon on freedom from above-ankle amputation, target lesion occlusion, and target lesion revascularisation. If approved, Lutonix would become the first drug-coated balloon indicated for BTK CLI, which according to Stifel analysts is a market worth hundreds of millions of dollars in the US alone. But even Becton bulls must recognise that this approval is highly unlikely, and indeed Becton itself does not include any revenues from Lutonix in the BTK setting in its sales guidance.
|Becton Dickinson’s peripheral interventional business|
|Annual sales ($m)|
|Drug coated balloons/stents*||111||132||157||184||+7%|
|Total Becton Dickinson interventional||3,762||4,381||4,876||5,371||+5%|
|Total medtech revenues||15,975||18,000||19,483||20,974||+4%|
|*Note: Lutonix is approved for above-the-knee critical limb ischaemia and dialysis fistulae. Source: EvaluateMedTech.|