“Severe risk of development without oxygen therapy, can be used by adult patients”
EMA companion review in progress… “It will be the basis of the application for EU sales approval”
[시사뉴스 황수분 기자] Celltrion’s novel coronavirus infection (Corona 19) antibody treatment’Recyronazu’ (ingredient name regdanvimab) was able to use this treatment according to country-specific judgment in Europe before official approval by the European Medicines Agency (EMA). .
In a press release on the 26th (local time), EMA issued a recommendation to use “regdanbimab can be used for treatment in adult COVID-19 patients who do not need oxygen therapy and are at high risk of developing severe disease.”
As a result, it is possible to use Leckirona in Europe according to country-specific decisions before the official approval of EMA, which is responsible for the evaluation of drugs in the European Union (EU).
EMA said it was reviewing the effectiveness of the treatment on outpatients for moderately mild COVID-19 adults who did not require oxygen therapy, and explained that legdanvimab was found to lower hospitalization rates.
However, he added that the result was not enough to conclusively conclude the benefits of this treatment for now.
According to EMA, “The Drug Use Advisory Committee (CHMP) is based on the reasonable and low-risk potential that Celltrion treatments provide clinical benefits despite uncertainties, and that Legdanbimab is used as a treatment option for patients with high risk of severe progression. We have concluded that we can use it.”
“This recommendation can be used to support national recommendations regarding the availability of this antibody therapy prior to (EMA’s) marketing approval,” EMA said.
EMA’s’rolling review’ for Celltrion treatment is still ongoing.
Companion review is a regulatory method used to quickly assess promising drugs or vaccines in public health emergencies. EMA began its screening for Celltrion treatments on February 24th.
The EMA explained that “when the companion review is finalized, it will be the basis for the EU’s marketing approval application for this drug.”