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  • FDA accepts NDA for HLB¡¯s rivoceranib
  • by Lee, Seok-Jun | translator Kim, Jung-Ju | Jul 18, 2023 05:29am
FDA's decision expected by May
HLB¡¯s US subsidiary Elevar announces the FDA¡¯s acceptance of its new drug application for rivoceranib
HLB¡¯s hepatocellular carcinoma treatment ¡®rivoceranib¡¯ has now entered FDA¡¯s review.

Yang-Gon Jin, Chairman of the HLB Group, announced on the morning of the 17th that ¡°HLB¡¯s US subsidiary Elevar received an ¡®NDA Filing Acceptance¡¯ letter from the FDA.¡±

Elevar submitted a new drug application (NDA) for rivoceranib on May 16 after completing a global Phase III study evaluating the efficacy and safety of rivoceranib+camrelizumab therapy.

The FDA assigned a target action date of May 16, 2024, under the Prescription Drug User Fee Act (PDUFA). Therefore, the decision will be made for the new drug within 10 months.

With the FDA¡¯s acceptance of the NDA, the company plans to accelerate preparations for
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