Aker BioMarine achieves NDI status for brain health ingredient

Published: 11-Aug-2023

The company has announced its ingredient has achieved new dietary ingredient (NDI) status in the United States, meaning LYSOVETA can be marketed to the general public

Aker BioMarine’s brain health ingredient, LYSOVETA, has officially achieved new dietary ingredient (NDI) status in the United States. 

This NDI approval allows Aker BioMarine to market LYSOVETA to the general adult population.

Highlights of the NDI Process for LYSOVETA: 

  • The FDA's NDI process is the highest regulatory benchmark that Aker BioMarine can achieve.
  • Under the NDI, Aker BioMarine can market LYSOVETA at 1.5 grams/day for the general adult population.
  • 7 years of dedicated R&D has led to the development of this cutting-edge dietary ingredient in the form of Lysophosphatidylcholine (LPC), redefining the way we approach brain health nutrition.
  • Several studies show how dietary LPC-DHA efficiently increases brain DHA content and improves brain function in animal studies, thus providing a novel nutraceutical approach for Improving cognitive decline during ageing

LYSOVETA is a novel dietary supplement for targeted delivery of lysophosphatidylcholine (LPC-EPA/DHA) derived from krill. DHA and EPA cannot be synthesised efficiently in the brain and must be transported across the blood-brain barrier (BBB). 

This transporter, known as the MFSD2A can be best described as a multifunctional gatekeeper in the brain. The MFSD2A is the major transporter for DHA/EPA uptake into the brain and only recognises esterified DHA and EPA in the form of lysophosphatidylcholine (LPC).

The LPC transport is critical for providing LPC as building blocks for formation of neurons and regulation of membrane phospholipid composition. MFSD2A is also present in other vital organs such as the eye and liver, highlighting the wide-ranging potential for beneficial effects of dietary LPC. 

LYSOVETA will be the first commercially available LPC ingredient in the market, and we have big ambitions for what this means for the future

- Matts Johansen, CEO at Aker BioMarine

“This NDI approval marks a major milestone for Aker BioMarine,” said Line Johnsen, SVP Science & Regulatory Affairs, Aker BioMarine. “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,” added 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.”

Johansen said: “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.”

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