And finally, statins not be used as monotherapy in patients with severe or very severe hypertriglyceridemia, although statins can be used to modify the risk of cardiovascular disease.
VX-661 was generally well-tolerated, both as monotherapy and in combination with ivacaftor, and most adverse events were mild to moderate in severity and similar between the treatment groups and those who received placebo.
He says the U.S. Food and Drug Administration will use this as their justification for returning Tysabri to the market as a monotherapy with a big "black box" warning about the risk of PML on the label.