The Food and Drug Administration has approved Amgen’s drug Repatha for patients as young as 10 years old who suffer from a genetic disorder that causes them to have very high cholesterol levels at a young age, the company announced.
Repatha reduces so-called bad cholesterol in a way that’s different from statins, the common drug used to fight the condition. Repatha earlier was approved for patients as young as 13.
The genetic condition affects 1 in every 250 people worldwide, the company said. High levels of LDL cholesterol associated with the condition accelerate the development of cardiovascular disease and an increased risk of heart attacks and other vascular conditions at an early age.
Because the pediatric version of inherited high cholesterol “is an under-recognized condition that can lead to premature coronary artery disease, it’s critically important to have additional treatments that can significantly lower cholesterol,” Katherine Wilemon, founder and chief executive at The FH Foundation, said in a statement. “FH” stands for familial hypercholesterolemia, the inherited defect in how the body recycles LDL cholesterol.
Repatha accounted for $286 million in net sales in Amgen’s second quarter this year. The drug also experienced 49 percent volume growth. Amgen is based in Thousand Oaks.
Approval for the drug was based on a study that showed monthly treatment with Repatha reduced LDL cholesterol by 38 percent. There were some side effects such as headaches and upper respiratory tract infections, but no new safety risks were identified.
“The approval of Repatha for pediatric patients with FH represents a much-needed adjunct treatment option for these children with genetically high cholesterol who are unable to manage their high LDL-C with other lipid-lowering agents alone,” David M. Reese, Amgen’s executive vice president of research and development, said in a statement.
Amgen’s stock closed at $213.11, down 50 cents or 0.23 percent on Monday, a day when the Nasdaq dropped .52 percent.