FRANKLIN LAKES, N.J.,
March 21, 2019 /PRNewswire/
-- 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 five-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 five 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
five 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 randomized portion
of the LEVANT 2 study extensively. There are several known
confounding factors for mortality over the five-year period.
Said simply, there are causes of mortality for some participants
that could not reasonably be attributed to paclitaxel (e.g.,
pre-existing cancer). When excluding those individual deaths,
the subset analysis of the randomized portion no longer crosses the
line to significance at five 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.
About BD
BD is one of the largest global medical
technology companies in the world and is advancing the world of
health by improving medical discovery, diagnostics and the delivery
of care. The company supports the heroes on the frontlines of
healthcare by developing innovative technology, services and
solutions that help advance both clinical therapy for patients and
clinical process for healthcare providers. BD and its 65,000
employees have a passion and commitment to help enhance the safety
and efficiency of clinicians' care delivery process, enable
laboratory scientists to accurately detect disease and advance
researchers' capabilities to develop the next generation of
diagnostics and therapeutics. BD has a presence in virtually every
country and partners with organizations around the world to address
some of the most challenging global health issues. By working in
close collaboration with customers, BD can help enhance outcomes,
lower costs, increase efficiencies, improve safety and expand
access to healthcare. For more information on BD, please visit
bd.com.
Contacts:
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Troy
Kirkpatrick
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Monique N.
Dolecki
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BD Public
Relations
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BD Investor
Relations
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858.617.2361
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201.847.5378
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troy.kirkpatrick@bd.com
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Monique_Dolecki@bd.com
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SOURCE BD (Becton, Dickinson and Company)