In its December meeting, the EMA’s Human Medicine Committee (CHMP) concluded that omega-3 fatty acid drugs were not effective in preventing further heart and blood vessel problems in patients with heart attack.
Since 2000, omega-3 fatty acid drugs have been approved for use in combination with other drugs after a heart attack in a dose of one gram per day in several EU countries.
Companies such as Pfizer, Mylan, Teva and Pronova BioPharma from BASF currently have marketing authorization for omega-3 drugs in a large number of European countries – including the UK, Spain, France, Croatia, Germany and the Netherlands.
“The conclusion, based on a review of data collected over the years, means these medicines will no longer be approved for such use,” the EMA said in its monthly CHMP update.
The CHMP opinion will now be forwarded to the European Commission, which will take a final legally binding decision applicable in all EU Member States.
Omega-3 fatty acid medications contain the fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are often found in fish oils and a variety of dietary supplements.
They are approved as medicines in many EU countries for the prevention of further heart diseases or strokes after a heart attack (in combination with other medicines) and for the reduction of certain types of blood lipids.
The EMA noted that while the data available at the time of approval showed some benefits in reducing serious heart and blood vessel problems, it added that the benefits were viewed as modest at the time.
The review dealt with the results of the 1999 open “GISSI Prevenzione” study, which supported the initial approval of these drugs, as well as with retrospective cohort studies, more recent randomized controlled studies and results of meta-analyzes.
“The review found that while the original GISSI Prevenzione open-label study found some relative risk reduction, these beneficial effects were not confirmed in recent randomized controlled trials,” the EMA said.
It added that while there were no new safety concerns, the balance between the benefits and risks of these drugs for preventing heart disease or stroke recurrence is “now negative”.
However, the CHMP committee noted that omega-3 medicines can still be used to reduce triglyceride levels (treatment of hypertriglyceridemia).
Harry Rice, PhD, vice president of regulatory and scientific affairs at the Global Organization for EPA and DHA Omega-3 Fatty Acids (GOED), commented on the news, noting that the CHMP review was stimulated by a meta-analysis in early 2018, JAMA Cardiology that was underserved itself.
“With recent positive results from large clinical trials, it’s hard to imagine how the agency came to its conclusion,” said Rice. “Unfortunately the EMA did not publish its full assessment so it is difficult to know.”