Lagevrio was voluntarily withdrawn from Europe

What are the alternative treatments?

Merck voluntarily withdraws its application for permission to the EU

Celltrion and Hanmi withdraw generics production

Merck has voluntarily withdrawn its European approval application for Lagevrio, an oral COVID-19 treatment.

 

The pharmaceutical industry is paying close attention to whether the global supply of this drug will continue.

 

Celltrion and Hanmi Pharmaceutical, which had already decided to produce and supply Lagevrio generics to developing countries, have withdrawn their plans.

 

Foreign media including Reuters reported on the 28th (local time) that Merck voluntarily withdrew its application for permission from the European Union (EU) for Lagevrio, an oral COVID-19 treatment.

 

It is an analysis that Europe is in fact stepping out of the process.

 

The EMA-affiliated CHMP recommended banning Lagevrio approval in February this year.

 

At the recommendation of the CHMP, Merck eventually voluntarily withdrew its application for authorization in the EU.

 

In the pharmaceutical industry, attention is focused on whether Lagevrio's exit will spread to other countries, including the United States.

 

Lagevrio is being supplied as a corona treatment in more than 25 countries, including Korea, the US, Japan, the UK, Australia, and China.

 

Regarding this, Merck drew a line, saying, "This decision will not affect the use of Lagevrio in countries where licensing or approval has already been completed." Lagevrio appeared in 2022, in the midst of the Corona-19 crisis.

 

Together with Pfizer Paxlovid, it was widely used as an oral corona treatment.

 

However, this year, the global pandemic situation has ended and its use has declined significantly.

 

In the pharmaceutical industry, there is an analysis that Merck has decided to withdraw from the European market due to declining marketability.

 

It is analyzed that the lower effect compared to Paxlovid also influenced the decision to withdraw voluntarily.

 

Lagevrio is a mechanism that inhibits viral replication.

 

Unlike Paxlovid, which lowered the risk of hospitalization and death due to corona by 89%, Lagevrio only reduced the risk of hospitalization and death by 30%, as shown in phase 3 clinical trials.

 

It is said that the treatment effect is low and the marketability is greatly reduced, and global demand is said to have decreased significantly.

 

After generating $5.684 billion in global sales last year, Lagevrio's sales have plummeted this year.

 

As a result, domestic biopharmaceutical companies that were trying to produce and supply Lagevrio generics to low- and middle-developed countries are also stepping back.

 

Celltrion Pharmaceuticals recently passed the bill to terminate the license agreement for Lagevrio generic production at the board of directors' meeting.

 

The company originally planned to produce Lagevrio generics at its Cheongju plant but decided to terminate the contract as the COVID-19 situation eased compared to the time of the contract.

 

Hanmi also signed a contract to produce Lagevrio generics last year but canceled it earlier this year.

 

Likewise, Hanmi Pharm explained that this is because demand has significantly decreased as the corona crisis turned endemic.

 

In the pharmaceutical industry, attention is focused on alternatives to Lagevrio, which is in the process of being virtually phased out.

 

Potential alternative drugs include Xocova, developed by Japan's Shionogi Pharmaceutical, and Xafty, which is being developed by Hyundai Bioscience.

 

Xocova is an oral COVID-19 treatment developed by Japan's Shionogi Pharmaceuticals.

 

Xocova is currently being supplied only in Japan with EUA.

 

Xocova recorded sales of close to 1 trillion won in Japan for four months from November last year to March this year.

 

The Japanese government purchased 2 million doses of Xocova for 104.7 billion yen under a supply contract with Shionogi.

 

In Korea, Ildong Pharmaceutical started the joint development of Xocova with Shionogi Pharmaceutical.

 

Earlier this year, Ildong Pharmaceutical applied for product approval of Xocova to the Ministry of Food and Drug Safety.

 

The review is still ongoing after 6 months.

 

Hyundai Bioscience is developing niclosamide, which was previously used as an insect repellent in Korea, as an oral corona treatment through drug re-creation clinical trials.

 

In phase 2 clinical trials, it was found that the time taken for improvement of corona symptoms was shortened by 4 days.

 

Hyundai Bioscience plans to proceed with EUA and product approval to the Ministry of Food and Drug Safety.