BD Issues Statement in Response to FDA’s Letter Announcing Long-Term Data Review of Paclitaxel Devices Used in PAD
March 22, 2019—BD (Becton, Dickinson and Company) has issued a statement regarding the recent FDA letter that announced the preliminary review of long-term data on the use of paclitaxel-coated balloons and paclitaxel-eluting stents in the treatment of peripheral artery disease (PAD). BD’s full statement reads in full:
FRANKLIN LAKES, NJ—March 21, 2019—BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued the following statement related to the recent letter from FDA to health care providers regarding paclitaxel-coated devices:
On March 15, the FDA issued a letter to health care providers regarding paclitaxel-coated devices used to treat peripheral arterial disease in the femoropopliteal artery. It is of critical importance that BD's customers and shareholders know that BD believes in its LUTONIX® drug-coated balloon (DCB) formulation and stands behind the robustness of its pre-clinical and clinical data. The totality of evidence from seven, separate LUTONIX® DCB studies continues to collectively demonstrate the safety and efficacy of these products, which offer an important treatment option for a vulnerable patient population. Over the past several months, BD has completed an extensive, comprehensive review of all available LUTONIX® DCB clinical data and these analyses continue to confirm the safety and efficacy of our products.
In its March 15 letter, the FDA stated, based upon their preliminary analysis of long-term follow-up data, that they see a potentially concerning signal of increased long-term mortality regarding the paclitaxel-coated device use. The FDA acknowledged that the cause for the increased risk of mortality is unknown, that there is a limited amount of long-term data (which creates variability in estimating mortality risk), and that the data was not designed to be pooled. Yet, the FDA determined to issue the letter primarily, it would appear, on a limited review of data from less than 1,000 patients combined from three studies with 5-year data (completed by BD, Medtronic, and Cook Medical).
BD's LEVANT 2 study enrolled 1,189 patients for the FDA panel's safety evaluation; this intent-to-treat (ITT) population was reevaluated at 5 years and we do not see a signal of increased long-term mortality in this large patient cohort (P = .198). While subset analysis of the randomized portion (476 patients) of the LEVANT 2 study did cross the line to significance (P = .046) at 5 years, the broader data set confirms the safety of this product and is larger than the pooled dataset referenced in the FDA letter.
BD has reviewed the patient-level data from [the] randomized portion of the LEVANT 2 study extensively. There are several known confounding factors for mortality over the 5-year period. Said simply, there are causes of mortality for some participants that could not reasonably be attributed to paclitaxel (eg, pre-existing cancer). When excluding those individual deaths, the subset analysis of the randomized portion no longer crosses the line to significance at 5 years. We have also engaged an independent third-party contract research organization (CRO) to repeat our analyses and perform its own.
In addition, we are collaborating with other industry stakeholders, the FDA, and the VIVA Physicians Group to support an independent patient-level meta-analysis. We plan to complete these independent analyses prior to the FDA's Advisory Committee Meeting (panel) that is anticipated for mid-June 2019.
Patient safety and product quality are the top priorities at BD. We remain confident in our LUTONIX® DCB formulation, and we look forward to collaborating with global regulators, academic societies and other thought leaders in the analysis of long-term, patient-level data and further investigating the important issue of safety and DCBs.
For details regarding these data and all news related to the ongoing controversy regarding paclitaxel use in PAD, please visit our comprehensive continuing coverage page.