Research & Development
Veloxis submits the ENVARSUS XR NDA with the US FDA for kidney transplant patients
8 March 2018 -

Biopharmaceutical company Veloxis Pharmaceuticals A/S said on Wednesday that it has filed its supplemental New Drug Application (sNDA) with the US Food & Drug Administration (FDA) for ENVARSUS XR (tacrolimus extended-release tablets) for the prophylaxis of organ rejection in kidney transplant patients.

The company stated it is seeking a new de novo indication for ENVARSUS XR (tacrolimus extended-release tablets) for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants.

In conjunction, the sNDA is based on data from the company's multinational phase 3 study LCP-Tacro 3002, which evaluated the safety and efficacy of Envarsus XR versus immediate-release tacrolimus capsules for the prevention of acute allograft rejection in 500 de novo adult kidney transplant recipients.

According to the company, 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.

Additionally, the 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, concluded the company.

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