The CHMP noted that Kynamro was effective at reducing LDL cholesterol levels in patients with homozygous and severe heterozygous familial hypercholesterolaemia.
Because the drug increases the risk of liver, lung and cardiovascular adverse events, CHMP recommends that dronedarone should be used only after alternative treatments have been considered.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency today recommended that mipomersen (Kynamro, Isis and Genzyme) not be approved for use in Europe.
In its review, CHMP concluded that dronedarone increases the risk of injury to the liver and the lungs and may increase the risk of cardiovascular side effects in some patients with non-permanent AF.
The FDA action follows a similar decision by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which announced last week that it had recommended that Pradaxa be contraindicated in patients with prosthetic heart valves.
The CHMP was also concerned by liver test results in patients taking Kynamro showing a build-up of fat in the liver and increased enzyme levels, and was not convinced that the company had proposed sufficient measures to prevent the risk of irreversible liver damage.