Alirocumab (Praluent) to Get New Indication in Europe


February 05, 2019

The PCSK9 inhibitor alirocumab (Praluent, Sanofi/Regeneron) has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for the additional indication of use in patients with established cardiovascular disease to lower LDL cholesterol levels, in combination with the maximum tolerated dose of a statin or alone in patients who are statin-intolerant or for whom a statin is contraindicated.

This new indication is based on data from the ODYSSEY OUTCOMES trial, published last year, which showed a 15% relative reduction in major adverse cardiovascular events with alirocumab (75 mg subcutaneous injection every 2 weeks) in patients who had experienced an acute coronary syndrome in the past year, whose LDL cholesterol level was at least 70 mg/dL (1.8 mmol/L), and who were already receiving a high-intensity statin or the maximum tolerated dose.

The positive recommendation, made at the CHMP meeting last week, has been passed on to the European Commission, which will make a final decision on approval of the new indication in the coming months.

Data from ODYSSEY OUTCOMES have also been submitted to the US Food and Drug Administration, with a target action date of April 28.

Review of NOAC Bleeding

The CHMP also announced that it has started a review of a study that examined bleeding risks with the novel oral anticoagulants apixaban (Eliquis, Bristol-Myers Squibb), dabigatran (Pradaxa, Boehringer Ingelheim), and rivaroxaban (Xarelto, Janssen).

The new review aims to assess whether the results of that study have implications for the use of these drugs in clinical practice and whether any changes to the conditions of use and current measures to minimize the risk for bleeding would be needed, it states.

The observational study, commissioned by the European Medicines Agency, assessed the risk for major bleeding with these products when used to prevent thrombotic events in patients with nonvalvular atrial fibrillation, in comparison with other oral anticoagulants.

Results from the study showed differences in the risk for major bleeding between these agents. They also raised concerns about the level of adherence in clinical practice to restrictions, special warnings, and precautions in the product information, the CHMP says.

Reexamination of Omega-3s Post MI

The CHMP also notes that it will reexamine its previous recommendation, made on December 13, 2018, that omega-3 fatty acid medicines are not effective in preventing further cardiovascular events in patients who have had a myocardial infarction (MI).

It notes that omega-3 fatty acid medicines have been authorized for use after MI in several EU countries since 2000, at a dose of 1 g/day, but recent data have not confirmed a benefit.

However, the recommendation that the products are not effective for such use has been challenged by some of the marketing authorization holders, who have requested a reexamination, which will now go ahead, the CHMP adds.


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