Kynamro Sales Discontinued
May 31, 2018 – Kastle Therapeutics has discontinued sales of Kynamro® (mipomersen sodium), an oligonucleotide inhibitor of apolipoprotein B-100 synthesis used as an adjunct therapy to treat high cholesterol in patients with homozygous familial hypercholesterolemia (HoFH).
The drug, which is delivered via subcutaneous injection, was removed from the market in anticipation of its manufacturer’s closing in mid-June. Kastle Therapeutics acquired Kynamro in 2016, and the drug was first approved by the FDA in 2013. It has no generic equivalents. Patients who take Kynamro are being transitioned to alternative therapies.
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.