HLB says EMA begins main review of bile duct cancer drug lirafugratinib
In short
HLB’s US subsidiary Eleba Therapeutics said the European Medicines Agency has begun the main review of its marketing authorisation application for the bile duct cancer drug lirafugratinib. Asia Economy reported the European filing was made on September 14 and the EMA notice came on October 1, shortly after the drug won full US FDA approval on September 23 under the product name LYRFIGTU. Eleba plans to launch the drug in the US in the fourth quarter and is testing it in other solid tumours in a global phase 2 trial.
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HLB’s US subsidiary Eleba Therapeutics said it has been notified by the European Medicines Agency that the main review of its marketing authorisation application for the drug lirafugratinib has begun, according to the business outlets Korea Economic Daily, Asia Economy, Chosun Ilbo and Newsis. Asia Economy and Chosun Ilbo said the EMA started the review on October 1. [ 1 , 2 , 3 , 4 ]
Asia Economy reported that Eleba filed the European application on September 14, seeking approval of lirafugratinib as a second-line treatment for patients with advanced or metastatic bile duct cancer that has FGFR2 fusion or rearrangement. The EMA notice came about half a month later, the outlet said. The other documents described the drug more generally as a bile duct cancer treatment. [ 1 , 2 , 3 , 4 ]
Lirafugratinib received full approval from the US Food and Drug Administration on September 23, according to Asia Economy, under the separate US product name LYRFIGTU, which the outlet writes as 리픽투. Korea Economic Daily also reported the FDA approval and said the product name was conditionally accepted; Chosun Ilbo said the drug had won full US approval. Eleba plans to launch the product directly in the US in the fourth quarter of this year, Asia Economy reported. [ 1 , 2 , 3 ]
Eleba is also running a global phase 2 trial, ReFocus202, in patients with various solid tumours carrying FGFR2 fusion or rearrangement, to assess the drug’s potential as a tumour-agnostic treatment, Asia Economy reported. [ 2 ]
Kim Dong-gun, chief executive of Eleba, said in remarks carried by Asia Economy that the entry into the main European review, after US approval, means procedures for global market expansion are proceeding smoothly, and that the company will respond to the EMA review while pursuing US commercialisation and wider indications. [ 2 ]
The documents do not state when the EMA is expected to decide the application or when a European launch might follow. [ 2 , 3 ]
Why it matters
The EMA main review is the step that precedes a possible European marketing authorisation, so it determines whether the drug can reach patients outside the United States. For HLB, a Korean company whose US arm Eleba holds the asset, the review extends a commercial push that began with US approval. The documents give no estimate of the European market size or of the likelihood of approval.
Key facts
- HLB’s US subsidiary Eleba Therapeutics said the European Medicines Agency has started the main review of its European marketing authorisation application for lirafugratinib. [ 1 , 2 , 3 , 4 ]
- Asia Economy reported the European application was filed on September 14 for second-line treatment of advanced or metastatic bile duct cancer with FGFR2 fusion or rearrangement. [ 2 ]
- The EMA began the main review on October 1, about half a month after the filing, Asia Economy and Chosun Ilbo reported. [ 2 , 3 ]
- Lirafugratinib received full US Food and Drug Administration approval on September 23 under the separate US product name LYRFIGTU, written by Asia Economy as 리픽투. [ 1 , 2 ]
- Eleba plans to launch the drug directly in the US in the fourth quarter of this year, Asia Economy reported. [ 2 ]
- Eleba is running a global phase 2 trial, ReFocus202, in patients with various solid tumours carrying FGFR2 fusion or rearrangement to assess a tumour-agnostic use. [ 2 ]
- Eleba chief executive Kim Dong-gun said procedures for global market expansion are proceeding smoothly and that the company will respond to the EMA review while pursuing US commercialisation and wider indications. [ 2 ]
Confirmed by several sources
- HLB’s US subsidiary Eleba Therapeutics said the European Medicines Agency has begun the main review of its marketing authorisation application for lirafugratinib. [ 1 , 2 , 3 , 4 ]
- The EMA began the main review on October 1. [ 2 , 3 ]
- Lirafugratinib received full approval from the US Food and Drug Administration. [ 1 , 2 , 3 ]
- The drug has a separate US product name, given as LYRFIGTU by Korea Economic Daily and as 리픽투 by Asia Economy. [ 1 , 2 ]
Still unclear
- The September 14 European filing date and the specific European indication — second-line treatment of advanced or metastatic bile duct cancer with FGFR2 fusion or rearrangement — come from Asia Economy alone. Single-source detail; the other documents describe the drug only as a bile duct cancer treatment.
- No decision date for the EMA review and no European launch timeline are given. The documents do not state them.
- The documents do not say where the application was filed or where the companies involved are based. No city or country of operations is specified, so the location of the event is unclear.
What local media are saying
Timeline, local time
- Korea Economic Daily reports that lirafugratinib has received US FDA approval and that the US product name was accepted. [ 1 ]
- Asia Economy reports the European application was filed on September 14 and that the EMA began its main review on October 1. [ 2 ]
- Chosun Ilbo reports Eleba Therapeutics received the EMA notice that the main review had started. [ 3 ]
- Newsis reports, in its headline, that the drug is in main review in Europe after the US. [ 4 ]