Celltrion's COVID drug given green light in 1st of 3-step review

입력 2021. 1. 18. 17:55
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Clinical phase 3 trial mandatory to establish statistical merit, panel of experts say
Regdanvimab (Celltrion)

Celltrion’s proposed COVID-19 treatment has won an OK in the first of the three-leg review by the Ministry of Food and Drug Safety, the agency said Monday.

The Korean drugmaker last week sought conditional use approval for its anti-COVID-19 monoclonal antibody treatment candidate regdanvimab, or CT-P59, becoming the first local firm to reach that stage in the race for a COVID-19 cure.

A panel of experts, comprising eight outside experts and four from the ministry, advised that the authorities approve regdanvimab on the condition the firm continues its ongoing global phase 3 clinical trials.

This is the first of the three-stage review process. The first group’s opinion will be followed by the central pharmacists council’s and final inspection committee’s reviews.

The ministry said the experts found nothing different from what Celltrion had announced a few days ago in saying that regdanvimab can expedite recovery by 3.43 days.

As for the time spent for a patient to test negative, the group found no significant difference between the cohort given regdanvimab and the cohort not given it. Nonetheless, regdanvimab appeared to decrease the amount of viral mass in the injected person and there appeared to be a trend of reduced hospitalization, but this is hard to say definitively due to the lack of statistical measurement in the clinical trial design, the experts said.

Among those who participated in the clinical trial of regdanvimab, no one died -- including those excluded from the injection. That makes it impossible to know the efficacy of regdanvimab in decreasing mortality.

Side effects from regdanvimab are higher-than-recommended neutral fat and calcium levels in the blood. No life-threatening side effects were discovered.

Based on the analysis, the consultation group gave approval for authorization of regdanvimab’s front-line use on the condition of a larger phase 3 clinical trial to corroborate statistical meaningfulness.

As of now, regdanvimab is recommended for use on patients over 18 years of age whose oxygen saturation level surpasses 94 percent in room environment, who do not need a ventilator and whose symptoms started to show seven days before injection.

In the phase 3 trial, Celltrion is advised to prove that enough patients were prevented from mild to moderate cases progressing to serious cases.

The Drug Ministry will request Celltrion submit additional data on regdanvimab, such as more safety data and raw material management data, in the final week of January.

Prime Minister Chung Sye-kyun had said Monday that should nothing go amiss in the process, regdanvimab would be in use from early February.

As for AstraZeneca vaccine, which the Drug Ministry is concurrently running evaluations on, additional data was requested Friday. Officials from the Drug Ministry are to visit AstraZeneca’s local contract manufacturing facility at SK Bioscience for field inspection in the final week of January.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)

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