On the 11th (local time), ‘Regkirona’, a COVID-19 antibody treatment developed by Celltrion in Korea, received an opinion of ‘approval recommendation’ from the Drug User Advisory Committee (CHMP) under the European Medicines Agency (EMA).
On the same day, CHMP recommended the approval of two types of antibody treatment for COVID-19, including Korea’s Celltrion’s Lekkorona and US pharmaceutical company Regeneron’s ‘Ronapreve’.
It is the first time that CHMP has issued an approval recommendation for an antibody treatment for COVID-19.
If Lekkorina is approved for end use, it will be the first domestic antibody drug to obtain EMA approval.
These treatments will be introduced to patients in European countries where COVID-19 is spreading at the fastest rate ever.
The CHMP is an organization that provides an opinion on whether to approve a drug to the EMA based on the results of scientific evaluation of a drug.
The CHMP’s approval recommendations are interpreted by the pharmaceutical industry to mean, in effect, European drug approval.
The European Commission (EC) receives the opinion of the CHMP and usually announces whether or not to approve the official product within 1 to 2 months.
The target of application of lekkorina recommended by the CHMP for approval is adults (18 years of age or older) with confirmed COVID-19 who do not need supplemental oxygen and are at high risk of transitioning to severe disease.
It is a method of administering the drug through a vein for 60 minutes, just like the one obtained the product approval in Korea.
It recommended that lonapreve be approved for use in the treatment of adolescents and adults 12 years of age and older, weighing at least 40 kg, who are at high risk of worsening into severe cases of COVID-19.
Lonapreve may be used to prevent COVID-19 in adults 12 years of age and older, CHMP added.
Previously, the two companies applied for a formal item authorization (MAA) with the EMA in early October, and the EMA had promised to give an opinion within two months.
The EMA reviewed various data submitted by Celltrion through a rolling review (preliminary review process before applying for permission) in February and issued a recommendation for approval of Rekkorina within a month of applying for official product approval.
While the approval recommendation process is in progress, these antibody therapeutics are already applicable to COVID-19 patients in the European Union (EU), Reuters reported.
US pharmaceutical company Eli Lilly withdrew its conditional approval application to the EU last week citing a lack of demand.
Recklona, which is considered the ‘first domestically produced’ Corona 19 treatment, received emergency use approval from the Indonesian Ministry of Food and Drug Safety (BPOM) and Brazil’s Food and Drug Administration (ANVISA) in July and August, respectively.
In September, we obtained official product approval from the Korean Ministry of Food and Drug Safety.
In Korea, as of the 5th, it is being actively used in 127 hospitals and administered to 21,366 patients.
With this EMA approval recommendation, Celltrion is on the verge of supplying Lekkorna to Europe’s first-line hospitals.
With this as an opportunity, we plan to further accelerate the development of suction type.
Inhaled lekkona is a method of inhaling a drug to deliver antibodies to the airway mucosa, and is being clinically tested in Australia.
Celltrion explains that the inhalation type is more convenient and more efficient than other methods because it allows self-treatment at home without having to go to the hospital.
(Photo = Yonhap News)