Shield Therapeutics PLC (AIM:STX, OTCQX:SHIEF) has said its iron deficiency product Accrufer/Ferracru is expected to secure regulatory approval in the Republic of Korea next year, after the Korean Food and Drug Administration agreed that a single pharmacokinetic study is the only additional requirement to support a New Drug Application (NDA) submission for Accrufer.
The commercial-stage pharmaceutical company said the study is expected to be initiated in the final quarter of 2022 and will be conducted by its partner Korea Pharma, which has development and commercialisation rights for Accrufer in Korea.
Korea Pharma expects regulatory approval allowing the commercial launch of Accrufer in late 2023.
READ: Shield Therapeutics’ lead product Accrufer has shelf-life extended to 48 months
Greg Madison, CEO of Shield Therapeutics, said in a statement: "We are delighted that the pathway to regulatory approval for commercialisation of Accrufer in Korea has been established, and that our partner, Korea Pharma, is now ready to commence the study required to support the NDA submission.
“There are an estimated 5.2 million people in the Republic of Korea with iron deficiency and iron deficiency anemia, in need of novel treatment options. We look forward to supporting our partner as they continue on the pathway to potentially make Accrufer available to patients."