LYRFIGTU wins U.S. FDA approval, now enters full EMA review; HLB gears up for Europe

[Financial News] HLB’s novel cholangiocarcinoma drug, having cleared the U.S. regulatory hurdle, is now setting its sights on the European market.
HLB said its U.S. subsidiary, Elevar Therapeutics, had been notified by the European Medicines Agency (EMA) that it had begun reviewing the marketing authorization application (MAA) for lirafugratinib, a novel cholangiocarcinoma drug.
On the 14th of last month (local time), Elevar applied for European marketing authorization for lirafugratinib as a second-line treatment for patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. Just over two weeks later, on October 1, the company was notified by EMA that a full review had begun, bringing the European authorization process into the substantive review stage.
Lirafugratinib had earlier received formal approval in the U.S. on September 23 under the brand name LYRFIGTU from the U.S. Food and Drug Administration (FDA). Elevar plans to launch LYRFIGTU itself in the U.S. in the fourth quarter of this year and aims to accelerate its entry into Europe following the start of the EMA review.
Work to expand its indications is also underway. Elevar is conducting the global Phase 2 clinical trial ‘ReFocus202’ in patients with various solid tumors bearing FGFR2 fusions or rearrangements, evaluating the drug’s potential as a tumor-agnostic therapy.
Elevar CEO Kim Dong-geon said, “With lirafugratinib, which received formal approval in the U.S. under the brand name LYRFIGTU, entering the full review stage in Europe as well, the process of expanding into global markets is proceeding smoothly. We will continue to increase lirafugratinib’s global value by responding diligently to the EMA review while pursuing commercialization in the U.S. and expanding its indications.”
 
[email protected] Jeong Myeong-jin, reporter