FDA notifies BD that Lutonix paclitaxel balloon PMA application for below the knee “not approvable in current form”

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lutonixThe US Food and Drug Administration (FDA) have denied BD premarket approval (PMA) for the company’s Lutonix drug-coated balloon (DCB) in the treatment of peripheral arterial disease (PAD).

Speaking in the company’s third quarter conference call on 6 August, BD CEO Vincent Forlenza told analysts: “Regarding our FDA, PMA submission for Lutonix below the knee [BTK], as you are all aware, we have been working with the FDA in a collaborative review process. Subsequent to the FDA Advisory Committee meeting on paclitaxel, the statutory review time for our BTK PMA submission concluded, and the FDA notified us that our PMA was not approvable in its current form.

“While this determination was based on the clinical evidence provided to-date, we continue to review, collaborate and align with the FDA on the path forward regarding our submission, including the need to potentially provide additional clinical data.

“As a result, the approval process timeline has extended out from our previous expectations and we no longer expect approval this calendar year. We will keep you informed as we work with the FDA and make further progress.”

Paclitaxel devices have come under regulatory scrutiny in the last eight months, following the publication of a meta-analysis in the Journal of the American Heart Association (JAHA) by Konstantinos Katsanos (Patras, Greece) and colleagues reporting an increased association of death when paclitaxel devices are used in the lower leg. The FDA analysed all available clinical randomised controlled trials or single-arm registries conducted with agency-approved devices with at least two year follow-up. The investigation compared drug-eluting or coated devices with non-eluting or coated devices.

At two years, the observed mortality rates for the paclitaxel-coated device group were higher for the Zilver PTX (Cook Medical) trial, Levant 2 (evaluating BD’s Lutonix DCB), and IN.PACT SFA I and II trials (looking at Medtronic’s Admiral DCB) in the FDA’s own analysis.

On the same call, the company reaffirmed its full-year revenue and earnings forecasts, and reported quarterly revenues of US$4.35 billion for the third fiscal quarter (which ended 30 June this year). According to a BD press release, this represents an increase of 1.7% over the prior-year period. The company state that on a comparable, currency-neutral basis, revenues increased 5.7% over the prior-year period.

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