Industry sources revealed on April 8th that AstraZeneca and HK inno.N are in the process of transferring approval for chronic heart failure and kidney failure indications, in addition to diabetes, to HK inno.N. This move precedes AstraZeneca's withdrawal plan for Farxiga (active ingredient: Dapagliflozin) in Korea. By providing safety and efficacy assessment data, it is anticipated that HK inno.N's product will gain approval for these indications.

Farxiga, initially approved as a second-line treatment for type 2 diabetes in 2013, gained additional indications for chronic heart failure in 2020 and chronic kidney failure in 2021 in South Korea. However, reimbursement was limited to diabetes treatment until February 2024 when it was extended to non-diabetic chronic heart failure patients. AstraZeneca had already decided to withdraw from the Korean market before this expansion.

The concern arises from potential price reductions in South Korea due to generic releases, impacting other countries. Despite scheduled price reduction, Farxiga's price remains at the existing cap due to an execution suspension.

AstraZeneca has partnered with HK inno.N for the distribution of Farxiga stocks and co-promotion of combination drugs, Xigduo Sustained Release Tablets (dapagliflozin + metformin) and Sidapvia Tablets (dapagliflozin + sitagliptin). The companies aim to ensure supply stability for patients and prevent inconvenience.

If HK inno.N's product gains approval for chronic heart failure and kidney failure indications for Farxiga, patent and PMS (post-marketing surveillance) issues need addressing. While Farxiga's diabetes treatment patents expired last April, patents for its use in treating heart failure and kidney failure remain. AstraZeneca may grant exclusive implementation rights for these patents to HK inno.N. PMS obligations may include filling in incomplete cases.

The best-case scenario involves AstraZeneca transferring approval for Farxiga's indications to HK inno.N, ensuring patients' continued dapagliflozin treatment. Deviations from this plan may lead to benefits from alternatives like Jardiance by Boehringer Ingelheim, the only available SGLT-2 inhibitor for patients with heart and kidney failure indications.

AstraZeneca officials declined to comment on the situation.