Lotus Pharmaceutical announced on February 20 that the U.S. Food and Drug Administration (FDA) has accepted its Abbreviated New Drug Application (ANDA) for Voclosporin soft capsules. This submission positions Lotus as a potential First-to-File (FTF) applicant for the generic version of Lupkynis, originally developed by Aurinia Pharmaceuticals Inc.

Lupkynis is the first and only FDA-approved oral therapy for adult patients with lupus nephritis (LN), used in combination with immunosuppressive therapy. According to Aurinia Pharmaceuticals' November 2024 report, Lupkynis generated approximately $159 million in U.S. sales over the past nine months, highlighting the substantial demand for effective LN treatments.

Market forecasts by GlobalData project that Lupkynis could reach peak U.S. sales of approximately $420 million by 2030.

Petar Vazharov, CEO of Lotus Pharmaceutical, emphasized the company’s strategic investments in unique dosage forms such as soft gel capsules, which provide a competitive edge in the market. The FDA’s acceptance of this application underscores Lotus' ability to develop complex and differentiated products successfully. Vazharov further noted that a significant portion of the company's R&D pipeline focuses on complex formulations, reinforcing Lotus' long-term growth strategy and expanding its diversified product portfolio.

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