Our spotlight today falls on Veloxis, a specialty pharmaceutical company based out of Hørsholm, Denmark. Veloxis is committed to transforming patient care in the organ transplant domain through the development and commercialization of their novel product, Envarsus®. This innovative drug aims to significantly reduce the rate of organ rejection in kidney transplant patients.
Advancing Patient Care with Envarsus®
Envarsus® (LCP-Tacro) is a once-daily dosage of tacrolimus, a market-leading primary immunosuppressant used widely in organ transplantation. Veloxis has demonstrated its non-inferiority compared to the established drug, Prograf®, in two separate Phase III clinical trials.
This potential game-changer has its roots in the company’s proprietary MeltDose technology, which optimizes the bioavailability of the drug and enables a sustained or modified release plasma profile. Already validated in clinical studies through the FDA’s approval of Fenoglide, this technology is shaping the future of treatment for transplant patients.
Strides towards Regulatory Approval and Market Authorization
In April 2013, Veloxis submitted a marketing authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market Envarsus® in the European Union. Fast forward to December 2013, the company filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® in the United States.
Simultaneously, Envarsus® was granted Orphan Drug status by the FDA for the prophylaxis of organ rejection in allogenic kidney transplant recipients. This major milestone points to the potential of Envarsus® to revolutionize the landscape of organ transplant care.
Nurturing Global Impact from Denmark
Founded in June 2002 as a spin-off from H. Lundbeck A/S, Veloxis has grown from a local Danish enterprise into an international entity with a fully-owned subsidiary in New Jersey, U.S. The company is listed on NASDAQ OMX Copenhagen A/S (OMX: VELO), marking its standing in the global pharmaceutical arena.
At the heart of Veloxis’s work is a commitment to advancing patient care and improving organ transplant outcomes. Through its cutting-edge research and innovation, Veloxis stands as a shining example of the European startup scene’s potential to bring meaningful changes to healthcare.
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