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Celltrion shares rose sharply Thursday after the Korean biotech company said the EMA’s human medicines committee (CHMP) started a rolling review of data on its monoclonal antibody Rekirona (regdanvimab), which is being developed for the treatment of Covid-19.
Celltrion shares gained 9.22 percent to close at 308,000 won ($278.03).
Rekirona was conditionally approved by Korean health authorities on Feb. 5 as the country’s first coronavirus cure and is now available at health institutes across Korea.
The EMA’s decision to start the rolling review is based on preliminary results from an ongoing study assessing the ability of the medicine to treat the infection.
A rolling review is a regulatory tool that the EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency. In a rolling review, data are reviewed as they become available from ongoing studies before a formal application is submitted unlike a general procedure where all data on a medicine’s effectiveness, safety and quality and all required documents must be submitted at the start of the evaluation in a formal application for marketing authorization.
The EMA said in a statement that it has not yet evaluated the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine. The EMA started evaluating the first batch of data, which come from animal studies and clinical trials.
The EMA will evaluate all data on this medicine as they become available and the rolling review will continue until enough evidence is available to support a formal marketing authorization application.
The EMA will also assess the medicine’s compliance with the usual standards for effectiveness, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review, the EMA added.
Celltrion said it is working to ensure speedy supply of Rekirona overseas upon authorization. The company already finished initial production of Rekirona to cover up to 100,000 patients and plans to roll out up to 3 million units a year depending on demand.
In parallel to the current cure and recognizing the global emergence of new coronavirus variants, the company has commenced development work against new variants with a cocktail therapy that combines a new neutralizing antibody and Rekirona. The new drug is being tested in Phase 3 clinical trials of some 1,200 patients with mild to moderate symptoms in 10 countries.
By Minu Kim
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