Celltrion wins COVID-19 treatment approval from Europe

South Korea’s pharmaceutical giant Celltrion Inc. has won final approval for its COVID-19 treatment Regkirona from the European Commission, a day after it secured a positive scientific opinion from a medical panel.

The European Medicines Agency (EMA) on Nov. 12 officially authorized use of two monoclonal antibody medicines – Regkirona and Ronapreve, co-developed by Regeneron Pharmaceuticals Inc. and Roche Registration GmbH, according to South Korean pharmaceutical industry sources on Nov. 14.

On Nov. 11, the EMA’s human medicines committee (CHMP) recommended authorizing both drugs for COVID-19 treatment.

“It usually takes one or two months to issue official permission after the committee recommends approval, but it took just one day this time,” said a Celltrion source. “It may have been influenced by the recent surge in COVID-19 confirmed cases.”

The number of infections has been hitting record highs every day in Germany, for example.

With the final authorization, Regkirona became the first monoclonal antibody drug, along with Ronapreve, for the pandemic approved by the EU and the first new medicine independently developed by a South Korean company to make inroads into the European market.

Eli Lilly, which sells COVID-19 treatments in the US, withdrew its medicines from the EMA review process, while GlaxoSmithKline has not received approval yet.

The EMA’s authorization is set to allow Celltrion to expand its markets of Regkirona into Europe from South Korea, Indonesia, Brazil and Pakistan.

SAFE AND EFFECTIVE

“Regkirona is a new drug that confirmed safety and effectiveness through tests of more than 20,000 patients in Korea,” said another Celltrion official.

There were no reports of deaths or serious side effects even as 21,366 took the medicine in the country as of Nov. 5.

One of the main tests involving 1,315 patients with COVID-19 showed that Regkirona led to fewer patients requiring hospitalization or oxygen therapy, or dying when compared with placebo, according to the EMA. Among the patients at increased risk of their illness becoming severe, 3.1% of patients treated with Regkirona were hospitalized, required supplemental oxygen, or died within 28 days of treatment compared with 11.1% of patients on placebo.

Regkirona is considered less convenient than Molnupiravir, the first oral treatment for COVID-19 developed by Merck & Co., as Regkirona is delivered through intravenous injection for 60 minutes.

Celltrion is confident of Regkirona’s success due to its effectiveness, however, even as global drugmakers are releasing easier-to-administer COVID-19 pills.

Regkirona reduced the risk of severe diseases by 70-72% in the high-risk group and shortened the clinical symptom improvement time by more than 4.7 days in the group, according to the results of the phase 3 clinical trial.

That compared with Merck’s Molnupiravir that cut the risk of deterioration by about 50%. The Merck tablet was also speculated to have some side effects such as DNA mutations that could lead to some types of cancer, according to media reports.

Pfizer said its COVID-19 pill cut the chances of hospitalization or death by 89% in high-risk adults who have been exposed to the virus, but it has yet to unveil details.

IN TALKS WITH FDA

Celltrion aims to expand Regkirona’s markets to other countries, especially the US. The company is in discussions with the US Food and Drug Administration (FDA) for emergency use authorization, although it has yet to be approved by the federal agency. Celltrion is also in talks with about 30 countries for permission or sales.

“We will accelerate entry into the US,” said the Celltrion source.

The company expected Regkirona’s demand to be strong as the gradual phaseout of COVID-19 restrictions across the globe has increased infections of the pandemic. Supply of the treatments was known to be short in the US with most medicines from Eli Lilly and Regeneron pre-ordered.

Celltrion is also developing an inhaled-type Regkirona, which has begun clinical trials in Australia.

Strong sales of Regkirona are expected to improve Celltrion’s earnings since the drug's margins are much better than biosimilars, its key products, even as it sells the COVID-19 treatment at 1.5 million-2.5 million won ($1,271-2,118) per bottle.

Some warned against over-optimism since it has to compete with oral treatments that are much easier to administer. Increasing vaccinations are also predicted to reduce the number of COVID-19 hospitalizations.

(Updated following the final approval)

Write to Sang-Hun Oh and Jae-young Han at ohyeah@hankyung.com
Jongwoo Cheon edited this article.