European Medicines Agency (EMA)-affiliated drug user advisory…recommended for use in patients with severe progression and high risk
The Drug User Advisory Committee (CHMP) under the European Medicines Agency (EMA) supported the use of Celltrion’s Corona 19 antibody treatment Rekirona (ingredient name Legdanvimab, project name CT-P59).
EMA announced on the 26th (local time) that the advisory committee concluded that Rekyrona can be used in adult patients with confirmed COVID-19 who do not need supplemental oxygen therapy and are at high risk of progressing to severe disease.
EMA explained that individual European countries had undergone a review by the Advisory Committee to help them based on scientific opinions in making decisions about the possibility of using Rekirona prior to its approval.
EMA reviewed ongoing research data and made recommendations based on the results to evaluate the effectiveness of Rekirona in adult outpatients with mild to moderate symptoms of COVID-19, who do not require adjuvant oxygen therapy.
In its recommendations, EMA said that the results of the first part of the study of Rekirona show that Rekirona can lower hospitalization rates, but that it is not strong enough to reach a firm conclusion on the benefits of Rekirona at this time. It was elaborate.
In addition, in terms of safety, reported side effects were mostly mild to moderate, and medical experts said that these reactions should be monitored as injection-related reactions, including allergic reactions, cannot be ruled out.
However, despite uncertainties, the CHMP concluded that Rekirona could be considered a treatment option for patients at high risk of severe progression, he added.
The EMA explained that the recommendations could be used in national decisions about availability prior to marketing authorization.
On the other hand, apart from this, EMA added that the rolling review of Rekirona, which began on February 24, is currently in progress, and that when the final review is completed, it will be the basis for the application for a European marketing license.
In order to accelerate the evaluation of promising treatments or vaccines in crisis situations such as pendemic, EMA’s companion review is a system in which data on the efficacy, safety, and quality of drugs are submitted in real time from the company before the final application for approval, and quickly reviewed by CHMP. .
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