Navamedic

Regulatory Filings • Apr 1, 2025

Navamedic Welcomes CHMP's Positive Review of Mysimba's Cardiovascular Safety

Navamedic Welcomes CHMP's Positive Review of Mysimba's Cardiovascular Safety

Oslo, Norway - [2025.04.01] - Navamedic is pleased to announce that the European

Medicines Agency's (EMA) human medicines committee (CHMP) has concluded its

review of Mysimba (naltrexone/bupropion), affirming that the benefits of the

medicine continue to outweigh its risks for weight management in adults with

obesity or overweight.

The CHMP has determined that there are no cardiovascular safety concerns for

Mysimba when used for up to 12 months. The CHMP has agreed that an ongoing

safety study with Mysimba in patients with obesity or overweight is appropriate

to generate evidence about this risk in the long term.

The ongoing safety study, INFORMUS, which is set to provide results by 2028,

will offer valuable insights into the long-term cardiovascular safety of

Mysimba. Annual reports will be submitted to ensure continuous evaluation and

transparency.

Navamedic will continue to work closely with healthcare providers to ensure that

they are informed of updated guidelines. Healthcare providers should carry out

an annual assessment of their patients whether Mysimba remains beneficial for

them.

Kathrine Gamborg Andreassen, CEO of Navamedic, commented on the review: "We are

encouraged by the CHMP's conclusion that Mysimba remains a beneficial option for

weight management. At Navamedic, patient safety is our utmost priority, and we

are committed to contribute to and ensure the long-term safety and efficacy of

Mysimba."

www.ema.europa.eu/en/news/ema-concludes-review-weight-management-medicine

-mysimba

INFORMUS Safety Study: https://clinicaltrials.gov/study/NCT06098079

For further information, please contact:

Kathrine Gamborg Andreassen, CEO, Navamedic

Mobile: +47 951 78 680

E-mail: kathrine@navamedic.com

Lars Hjarrand, CFO, Navamedic

Mobile: +47 917 62 842

E-mail: lars.hjarrand@navamedic.com

About Navamedic

Navamedic ASA is a Nordic pharmaceutical company dedicated to enhancing people's

quality of life by being a reliable supplier of high-quality prescription,

consumer health, and hospital products to hospitals and pharmacies. Our growing

product portfolio has been carefully selected to meet current public health

concerns, such as obesity, Parkinson's disease, and gastro-related ailments, to

empower people to live healthier and more fulfilling lives.

What sets us apart is our deep-rooted commitment to understanding the needs and

requirements of the countries where we are present. Our local insight and

competence enable us to understand the specific needs of each country where we

operate and ultimately to gain market access. This makes us a preferred partner

for international companies expanding their footprint across the Nordics and

Benelux regions, through either in-licensing or out-licensing. Navamedic has

been listed on the Oslo Stock Exchange since 2006 (ticker: NAVA) and is

headquartered in Oslo, Norway.

For more information, please visit Navamedic.com

This information is subject to the disclosure requirements pursuant to section 5

-12 of the Norwegian Securities Trading Act.