Baxter wins FDA De Novo for more expansive dialyzer

Renal care is Baxter’s largest business line and has become especially important during 2020 as acute kidney injury has proven to be a complication of COVID-19, raking in nearly $1.79 billion during the first six months of the year, up 5% year over year at constant currency. The need for dialysis therapies around the world is driving demand and FDA has issued a few emergency use authorizations for Baxter supplies.

Theranova, which given is considered a “medium cut-off” dialyzer as opposed to “high-flux,” may represent an important addition to that mix. The product has been commercially available in Europe and other parts of the world since 2016 and Baxter has already opened orders in the U.S. with an expected turnaround time of about a week.

The dialyzers are designed for use with conventional hemodialysis, which can occur in a clinic or at home — the latter setting has piqued the Trump administration’s interest as a way to reduce how much the government pays for costly in-center treatments. But the majority of clinical data available on Theranova is from in-center use, a spokesperson clarified.

The device was under review by FDA for almost a year. Baxter backed its FDA submission with findings from a randomized controlled trial of 172 hemodialysis patients, results of which were published in the Clinical Journal of the American Society of Nephrology this month. The trial, run across 21 U.S. sites between 2017 and 2018, compared outcomes in patients given the Theranova 400 dialyzer over 24 weeks to those given ELISIO-17H, a high-flux dialyzer from renal care product manufacturer Nipro. Patients receiving Theranova were found to have had superior removal of large middle molecules.

In early July, CMS proposed additional payment to providers for at-home dialysis treatment as part of changes to its ESRD PPS. Baxter, like fellow applicant and dialysis tech newcomer Outset Medical, is yet to be successful in obtaining the add-on payment. Read more

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