Celltrion applies for Covid-19 treatment conditional use permit
Celltrion submitted an application to obtain a conditional use permit for its Covid-19 treatment candidate CT-P59 on Tuesday.
The bio pharmaceutical company, more widely known for its biosimilars, said it recently completed Phase 2 clinical trials for CT-P59 and considers the results sufficient to provide grounds to the government body for a conditional approval — “conditional” in a sense that Celltrion would still be required to submit Phase 3 clinical trial results in the future.
With the Phase 2 trials finished, Celltrion will also prepare to obtain emergency use authorization in the United States and Europe as well, it added Tuesday. The aim is to submit applications to the drug regulators in each region in January.
In Korea, the Ministry of Food and Drug Safety will take charge of the screening and approval of the permit. The government body said Tuesday it immediately started checking Celltrion’s papers.
“We plan to supply CT-P59 to medical institutions as soon as the conditional permit arrives,” the bio pharmaceutical company said in a public filing Tuesday.
Under a government initiative to speed up authorization for Covid-19 treatments and vaccines, CT-P59 may be available in domestic hospitals within 40 days.
Under normal circumstances, government-approved pharmaceuticals are directly purchased by hospitals. But considering Covid-19 treatments are part of a government-led initiative, it's likely that the government will be involved in purchasing and distributing CT-P59.
“We expect [CT-P59] to be effective in treating Covid-19 patients with light to moderate symptoms,” the ministry said in a Tuesday statement. “The product takes the form of an intravenous injection that is directly injected into the vein for 90 minutes.”
CT-P59, which also goes under the substance name regdanvimab, is an antibody treatment in which the antibody neutralizes the coronavirus’ activity in the body. In Korea, it was one of the first coronavirus treatment candidates appointed to receive government funding in May.
If the treatment candidate does receive a marketing permit, CT-P59 would be second after Gilead Sciences’ remdesivir and the first domestic-made Covid-19 treatment to be permitted as an official Covid-19 drug available in Korea.
It is also the third antibody treatment in the world to apply for a government use permit, following treatments from Eli Lilly and Regeneron, according to the Drug Safety Ministry.
Phase 2 clinical trials for the treatment candidate were conducted on 327 patients with mild to moderates symptoms in Korea, Romania, Spain and the United States. The test was designed upon discussions with the drug administration bodies of Korea, the United States and Europe.
The company had originally planned to disclose Phase 2 clinical trial results to the public by the time it applied for a use permit in Korea. However, that schedule was delayed to the first half of 2021.
“We do have the results but there was a request from the Ministry of Food and Drug Safety that considering the high level of public interest, it wanted to review the data and release it later as part of a government announcement,” a Celltrion spokesman said.
Detailed clinical data from Phase 2 trials will be shared at an international conference, Celltrion said in a statement, for which details were not disclosed.
Phase 3 clinical trials for CT-P59 are planned to be conducted on a larger group of 720 patients with light to moderate symptoms.
Whereas the Phase 2 tests focused on verifying the treatment candidate’s ability to reduce the recovery period, Phase 3 trials will observe whether it is effective in reducing the portion of patients whose conditions would have aggravated to requiring hospital care or oxygen therapy without the drug.
CT-P59 is currently approved for Phase 3 clinical trials in Korea, Romania, the United States, Britain, Spain and Italy.
BY SONG KYOUNG-SON [firstname.lastname@example.org]