Aker BioMarine has announced that its brain health ingredient, Lysoveta, has received an acknowledgement letter from the U.S. Food and Drug Administration (FDA) following its new dietary ingredient notification (NDIN).
Aker BioMarine (Oslo, Norway) has announced that its brain health ingredient, Lysoveta, has received an acknowledgement letter from the U.S. Food and Drug Administration (FDA) following its new dietary ingredient notification (NDIN). Lysoveta is lysophosphatidylcholine (LPC) – bound EPA and DHA from krill. Aker developed the ingredient based on research that determined that LPC was the primary carrier molecule taking DHA across the blood brain barrier through a transport protein called Mfsd2A.1 According to the company, LPC is also present in the eye and liver, highlighting other potential benefits for supplementation with LPC.
“This NDI approval marks a major milestone for Aker BioMarine,” says Line Johnsen, senior vice president of Science & Regulatory Affairs, Aker BioMarine, in a press release. “We are currently conducting research to help make LPC bound EPA and DHA the go-to solution for brain health and working with well-established area experts to uncover commercial opportunities for Lysoveta. The recent FDA status was the next milestone in making this all happen.”
“Over the span of the last seven years, the unwavering dedication of our R&D team has fueled the development of this remarkable ingredient,” adds Matts Johansen, CEO at Aker BioMarine. “We have a dedicated production line for Lysoveta in our Houston factory and have invested millions of dollars (USD) to bring this ingredient to life. As the leader in krill-derived supplements, we understand the full potential of this ingredient. Lysoveta will be the first commercially available LPC ingredient in the market, and we have big ambitions for what this means for the future. To that end, we are pushing forward with clinical trials and looking for customer partnerships to help take the brain health market to new heights.”
With the acknowledgment from FDA, commercialization of Lysoveta in the U.S. is imminent. Last year, Aker signed a commercial agreement with Trofi Nutritional (Northbrook, IL). As part o of the agreement, Aker is licensing and supplying Lysoveta to Trofi, who will develop and commercialize medical foods targeting male infertility, gestational diabetes, and Alzheimer’s disease, as well as dietary supplements for pregnant women.