Aker BioMarine receives regulatory boost in Australia for krill oil

Published: 6-Sep-2023

The Australian Register of Therapeutic Goods (ARTG) has included Aker BioMarine’s Superba Boost Krill oil as an ‘assessed listed’ medicine

Aker BioMarine’s Superba Boost Krill oil, used by the Swisse brand in Australia, is now included in the Australian Register of Therapeutic Goods (ARTG) as an ‘assessed listed’ medicine.

Swisse Ultiboost High Strength Krill Oil, which uses Aker BioMarine’s Superba Boost Krill oil, has been included on the Australia Register of Therapeutic Goods (ARTG) with an AUST L(A) 417392 with two specific indications, those being: 

  • Decrease/reduce/relieve knee pain and stiffness in mild to moderate osteoarthritis.
  • Increase knee physical function in mild to moderate osteoarthritis.

All medicines supplied to the Australian market must be included in the ARTG. The ‘assessed listed’ medicine status of Swisse’s Ultiboost High Strength Krill Oil containing Superba Boost, means that it has been reviewed to assess the efficacy of its health claims, prior to being officially added to the country’s register for medicines.

This study demonstrates our commitment to contributing to the body of research focusing on complementary medicines

- Nick Mann, the Australian CEO of Swisse 

With its newly secured Listing ARTGL (A) 417392, Swisse Ultiboost High Strength Krill Oil can now add information about the health benefits of the Superba Boost Krill Oil to its label and include these messages in consumer advertising. The specific indications are exclusive to Swisse for the next five years.

“This study came after decade’s worth of scientific research focused on uncovering the full potential of krill and is a testimony to the unique nature and effectiveness of Aker BioMarine’s Antarctic krill oil ingredient,” said Line Johnsen, SVP Human Health & Nutrition R&D, Aker BioMarine.

“Aker BioMarine has continually invested in research in many countries and at different times and this research consistently shows that this powerful omega-3 source is both safe to consume and can lead to improvements in knee pain, stiffness, and physical function in adults, in addition to heart and brain benefits,” added Johnsen.

"It is great to see companies like Swisse Wellness securing access to this regulatory pathway. It is a recognition of their ongoing commitment to research to enable new innovative products. It means more specific evidence-based information for consumers and highlights the benefits of complementary medicines. It also demonstrates that Australia is a world leader in the research and development of complementary medicines,” said John O’Doherty, CEO Complementary Medicines Australia.

Recent CSIRO trial concludes Superba Boost can help to reduce knee pain in adults with mild to moderate osteoarthritis.

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A clinical trial was recently executed under the guidance of Australia's national science agency, CSIRO, to evaluate the impact of krill oil on osteoarthritis of the knee. 

The study, which was sponsored by Swisse's H&H Research, the research arm of global health and nutrition company, H&H Group, was conducted across three clinical trial sites in Australia and evaluated 235 adults between 40 to 65 years of age who had been clinically diagnosed with mild to moderate knee pain.

The results showed that not only did Superba Boost significantly reduce the pain, but it also helped improve stiffness and physical function in the participant’s knees.

"This study demonstrates our commitment to contributing to the body of research focusing on complementary medicines and in turn displays our dedication to delivering innovative and efficacious products to our consumers," said Nick Mann, the Australian CEO of Swisse. 

The efficacy of an ‘assessed listed’ medicine is evaluated pre-market, which is a prerequisite for the use of the “TGA assessed” claim on the label.

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