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August 6, 2019

BD Extends Lutonix BTK Timeline as Submission to FDA Deemed Not Approvable in Current Form

August 6, 2019—In Becton, Dickinson & Company's (BD) earnings call to investors for the third fiscal quarter of 2019, Chairman and Chief Executive Officer Vincent A. Forlenza reported on the status of the company's submission of its premarket approval (PMA) application to the FDA for an indication for the Lutonix paclitaxel-coated balloon to treat peripheral artery disease below the knee (BTK).

The BD Interventional segment of the company has been working with the FDA in a collaborative review process. The statutory review time for the BTK PMA submission concluded and the FDA notified BD that "the PMA was not approvable in its current form." This determination was based on the clinical evidence provided to date; however, the company continues to "review, collaborate, and align with the FDA on the path forward regarding our submission, including the need to potentially provide additional clinical data," stated Mr. Forlenza.

As a result, the company's approval process timeline has extended from previous expectations and it no longer expects approval this calendar year, advised Mr. Forlenza in the BD earnings call.

In November 2018, the safety and efficacy data from the level 1 investigational device exemption clinical trial of the Lutonix DCB for a BTK indication were presented at VIVA 2018, the Vascular Interventional Advances annual conference held in Las Vegas, Nevada.

In that presentation, the investigators reported that the study's primary safety endpoint (freedom from a composite of all-cause death and above-the-ankle or major reintervention of the treated limb through 30 days) was met and showed statistically significant safety equivalence between the Lutonix 014 DCB and a standard percutaneous transluminal angioplasty (PTA) catheter in both proportional/binary and Kaplan-Meier analyses.

The primary efficacy endpoint, assessed using a composite measurement of limbs saved from amputation and primary patency at 6 months, showed an improvement in primary efficacy of 10.2% for DCB compared with PTA (73.7% vs 63.5%; P = .0273, not significant) by proportional/binary analysis. As measured by Kaplan-Meier analysis, the primary efficacy endpoint demonstrated a significant difference of 14.6% for DCB compared with PTA (85.3% vs 70.7%; P < .001). Additional analyses are planned for 12-, 24- and 36-month follow-up noted the company at VIVA.

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