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Nxera Pharma Submits <a href="https://bitcomme.com/47-essential-digital-marketing-statistics-for-2026/” title=”47 Essential digital marketing statistics for 2026″>Marketing Authorization Application for Vamorolone in South Korea for the Treatment of Duchenne Muscular Dystrophy
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Submission marks an important milestone towards bringing a new treatment option to patients with DMD in South Korea.
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Vamorolone has already received South Korean Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation.
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Targeting regulatory approval in South Korea in 2027 and commercial launch in 2028.
Tokyo, Japan and Cambridge, UK, 22October 2026 – Nxera Pharma Co., Ltd. (“Nxera” or the “Company”) announces that it has submitted a Marketing Authorization Application (MAA) to the Ministry of Food and Drug Safety (MFDS) in South Korea for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
As announced on 2 June 2026, vamorolone has received Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation in South Korea. GIFT is a priority review pathway designed to accelerate the review of innovative medicines targeting life-threatening or serious diseases, including rare diseases, and is expected to help shorten the review timeline and support earlier patient access to vamorolone. The Company is targeting marketing authorization in South Korea in 2027, followed by a commercial launch in 2028.
In January 2026, Nxera acquired exclusive rights from Santhera Pharmaceuticals Holding (“Santhera”) to develop, manufacture and commercialize vamorolone in Japan, South Korea, Australia and New Zealand. Nxera is leading regulatory approval, commercialization and manufacturing activities in these territories. Vamorolone is a dissociative corticosteroid developed to preserve anti-inflammatory efficacy while reducing the systemic side effects associated with long-term conventional corticosteroid therapy. It is approved and marketed for the treatment of DMD in the US, European Union, UK and China.
Mr. MinBok Lee, President and Representative Director of Nxera Pharma Korea,commented: ” This submission marks an important milestone towards bringing a new treatment option to patients with DMD and their families in South Korea. Following the ODD and GIFT designations, we are very pleased to have reached this submission milestone as planned. DMD is a serious, progressive disease requiring long-term treatment, and we believe vamorolone has the potential to address an important unmet medical need by offering a differentiated treatment option with a more favorable long-term safety profile. We will continue to explore ways to bring vamorolone to Korean patients sooner, while working closely with the regulatory authorities towards approval.”
