In its December meeting, the EMA’s human medicines committee (CHMP) concluded that omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a heart attack.
Omega-3 fatty acid medicines have been authorised for use after a heart attack – in combination with other medicines – in several EU countries since 2000, at a dose of one gram per day.
Companies including Pfizer, Mylan, Teva and BASF owned Pronova BioPharma currently hold market authorisation for omega-3 medicines in a variety of European countries – including the UK, Spain, France, Croatia, Germany and the Netherlands.
“The conclusion, based on a review of data accumulated over the years, means that these medicines will no longer be authorised for such use,” said the EMA in its monthly CHMP update.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
Omega 3-fatty acid medicines contain the fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – which are commonly found in fish oils and a wide variety of dietary supplements.
As a medicine, they are authorised in many EU for the prevention of further heart disease or stroke after a heart attack (in combination with other medicines) and for reducing certain types of blood lipids.
The EMA noted that while the available data at the time of the authorisation showed some benefits in reducing serious problems with the heart and blood vessels, but added that the benefits were considered modest at the time.
The review looked at results of the open-label ‘GISSI Prevenzione’ study performed in 1999 which supported the initial authorisation of these medicines, as well as retrospective cohort studies, more recent randomised controlled trials and results of meta-analyses.
“The review concluded that, while a small relative risk reduction was seen in the original open-label GISSI Prevenzione study, such beneficial effects were not confirmed in more recent randomised controlled trials,” said the EMA.
It added that although there were no new safety concerns, the balance between the benefits and risks of these medicines to prevent recurrence of heart disease or stroke ‘is now negative.’
However, the CHMP committee noted that omega-3 medicines can still be used to reduce levels of triglycerides (treatment of hypertriglyceridaemia).
Commenting on the news, Harry Rice, PhD, vice president of regulatory and scientific affairs at the Global Organization for EPA and DHA Omega-3s (GOED), noted that the CHMP review was stimulated by a meta-analysis at the beginning of 2018 in JAMA Cardiology, which itself was under-powered.
"It's hard to imagine how the Agency came to its conclusion, given the recent positive results from large clinical trials," Rice said. "Unfortunately, the EMA hasn't posted its full review, so it's difficult to know."