Sanofi-Aventis Korea has extended the expiration date of its hemophilia A treatment Eloctate (efmoroctocog alfa) in Korea, following a controversy over mislabeling the drug's expiration date.
Sanofi said Wednesday that it has received approval from the Ministry of Food and Drug Safety (MFSD) to extend the expiration date of Eloctate in Korea. Accordingly, the expiration date of Eloctate has been extended from 36 months to 48 months from the date of manufacture.
Sanofi explained that it prepared and submitted data to the MFDS by the relevant domestic regulations to align the domestic expiration date with the overseas expiration date of 48 months from the date of manufacture. With the approval of this change, packages of Eloctate imported to Korea will have an expiration date of 48 months.
The expiration date change follows a controversy late last year over an error in the expiration date labeling. On Dec. 22 last year, Sanofi announced a voluntary recall of some manufacturing numbers (SP2103, SP2109, SP2211) of Eloctate (250IU, 1000IU).
The reason for the recall was an error in the expiration date labeling.
Sanofi explained that some of the products supplied in Korea were labeled with expiration dates abroad. Some products were supplied to medical institutions or patients even though the expiration date had expired according to the domestic license.
In response, Sanofi submitted a recall action plan to the MFDS and posted a notice on its website to request drug distributors and medical institutions to stop selling and return the recalled products.
Sanofi's decision to extend the expiration date will likely prevent a repeat of previous expiration date misstatements. It has been nearly four years since Eloctate was launched in Korea in June 2020.
"While there has been confusion in the market due to the difference in the duration of use between the overseas and domestic licenses for the same product, the approval of the 48-month domestic expiration date for Eloctate is expected to make it easier for patients to store and handle the drug in the medical field and at home," said Park Hee-kyung, president of Specialty Care Division at Sanofi-Aventis Korea.
Park added that Sanofi remains committed to prioritizing patient safety and enabling patients to manage their conditions better.
Eloctate is a hemophilia A treatment developed by U.S. pharmaceutical company Bioverativ, which features an extended half-life of factor 8. It was licensed domestically by Korea UCB Pharmaceutical. However, Sanofi-Aventis Korea acquired Bioverativ in 2018 and launched the drug in Korea in 2020.