Repatha Receives New Indication to Reduce Cardiovascular Events
December 1, 2017 – The U.S. FDA has approved a new indication for Repatha® (evolocumab), manufactured by Amgen, to decrease the risk of cardiovascular (CV) events in patients who have existing cardiovascular disease. Repatha was originally approved in 2015 to treat certain patients who need additional help lowering low-density lipoprotein (LDL) cholesterol when diet and other approaches, such as maximum dosing of statins, prove insufficient.
The new indication is based on a clinical trial in which Repatha was shown to decrease the risk of heart attack by 27%, and the risk of stroke by 21%, when combined with appropriate use of statins. A proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, Repatha works by targeting a specific protein and rendering it inactive. This reduces the amount of LDL cholesterol in the bloodstream. Lower levels of LDL cholesterol have been shown to improve cardiovascular health and reduce the risk of cardiovascular events, such as strokes and heart attacks.
Recommended dosing for Repatha is either 140mg taken every two weeks, or 420mg taken once monthly. In patients with homozygous familial hypercholesterolemia (HoFH), Repatha should only be given as a 420mg dose once monthly. The 420mg dose should be administered over the course of 9 minutes, or as three separate, consecutive injections within a 30-minute timespan.
Repatha is available in a 140mg/mL solution in either a single-use prefilled syringe or autoinjector, and in a 420mg/3.5mL solution in a single-use on-body infuser with prefilled cartridge. Patients can self-administer Repatha once trained in proper technique by a healthcare professional.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.