The panel voted unanimously to approve the drug, known also as evolocumab, for patients with homozygous familial hypercholesterolemia (HoFH), a hereditary disorder that causes high LDL and can cause heart attacks in very young people, including children.
They voted 11-4 to approve Repatha in patients with high cholesterol who are at high risk of cardiovascular disease whose cholesterol cannot be lowered sufficiently using statins or other drugs.
AMGN was flattish in regular-hours trading and is +1% in the AH session.
ESPR was -19% in regular-hours trading and is +1% in the AH session.
REGN was -3% in regular-hours trading and is flattish in the AH session.
This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies. Esperion plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.