Veloxis Files with FDA for the De Novo Indication for ENVARSUS XR
08 March 2018 - 7:16AM
Veloxis Files with FDA for the De Novo Indication for ENVARSUS XR
Company Release no. 03/2018
To: NASDAQ Copenhagen
A/S
Copenhagen, Denmark, 07 March 2018
Veloxis Files with FDA for the De Novo
Indication for ENVARSUS XR®
Veloxis Pharmaceuticals A/S announced today that
it has submitted a supplemental New Drug Application (sNDA) to the
U.S. Food & Drug Administration (FDA) seeking a new indication
for ENVARSUS XR (tacrolimus extended-release tablets) for the
prophylaxis of organ rejection in kidney transplant patients in
combination with other immunosuppressants. This indication is
commonly referred to as the de novo indication.
Craig Collard, CEO of Veloxis Pharmaceuticals
A/S said “We are excited to re-file for the de novo indication for
ENVARSUS XR and look forward to working with FDA as it reviews our
filing.”
The sNDA is based on data from multinational
phase 3 study LCP-Tacro 3002, which evaluated the safety and
efficacy of ENVARSUS XR compared to immediate-release tacrolimus
capsules for the prevention of acute allograft rejection in over
500 de novo adult kidney transplant recipients. The primary
endpoint was the incidence of treatment failures within 12
months. Treatment failure was a composite endpoint that
included death, graft failure, biopsy-proven acute rejection or
lost to follow-up. Results showed treatment failure rates of
18.3% for the ENVARSUS XR group and 19.6% for the immediate-release
tacrolimus capsules treatment group, demonstrating ENVARSUS XR as
non-inferior to immediate-release tacrolimus capsules.
ENVARSUS XR was approved by the FDA on 10 July
2015 for the prophylaxis of organ rejection in kidney transplant
patients converted from tacrolimus immediate-release formulations
in combination with other immunosupressants. Veloxis’s
original New Drug Application (NDA) for ENVARSUS XR sought approval
for the de novo indication and was filed on 30 December 2013.
FDA tentatively approved ENVARSUS XR for the de novo indication on
30 October 2014; however, final approval was blocked by the
exclusivity of ASTAGRAF XL® which expired on 19 July
2016.
For more information, please
contact:
Craig A.
Collard
President &
CEO
Phone: +1 919 591
3090
Email:
cac@veloxis.com
About Veloxis
Pharmaceuticals
Veloxis Pharmaceuticals A/S is a
biopharmaceutical company focused on improving patient lives by
identifying, developing, and commercializing meaningful products in
transplantation and adjacent therapies. Utilizing our proprietary
drug delivery technology, MELTDOSE®, Veloxis has developed and
obtained FDA and EMA approval for our product, ENVARSUS XR®
(tacrolimus extended-release tablets), to aid in the prophylaxis of
organ rejection in transplant recipients. Our strategy is to
continue to commercialize Envarsus XR in the U.S. with a direct
salesforce and to license rights to Envarsus to proven commercial
partners in other territories around the world. In addition
to expanding use of Envarsus, Veloxis is actively seeking business
development and licensing targets within the areas of
transplantation and adjacent specialties, and therapeutics for rare
or severe disease for which chronic therapy is initiated in the
large hospital setting. Veloxis is listed on the NASDAQ OMX
Copenhagen under the trading symbol OMX: VELO. For further
information, please visit www.veloxis.com.
2018.03.07 - Company Release 03 - Veloxis Files for De Novo
Indication
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