The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for South Korean company Celltrion’s regdanvimab (CT-P59) to treat Covid-19.
According to the CHMP recommendation, the anti-Covid-19 monoclonal antibody treatment candidate regdanvimab can be used for treating patients who are at a high risk of progressing to severe Covid-19, based on a reasonable possibility that the medicine could offer clinical benefit and a reduced chance of causing harm.
Furthermore, the EMA began a rolling review of regdanvimab based on data from animal studies (non-clinical data) and clinical trials, along with data on the medicine’s quality.
Celltrion Healthcare Medical and Marketing Division head Dr HoUng Kim said: “Today’s CHMP positive scientific opinion by the EMA takes us a significant step closer to providing a safe and effective monoclonal antibody treatment against Covid-19 worldwide.
“Based on clinical data and CHMP’s positive scientific opinion, regdanvimab has been adopted and contracts for initial supplies have been made with distributors towards Nordic countries including Denmark, Norway, Sweden and Finland.”
In a separate development, the EMA has approved storage of Pfizer and BioNTech’s Covid-19 vaccine, COMIRNATY, at -25°C to -15°C for two weeks based on data which demonstrated its stability at these temperatures in standard pharmaceutical freezers.
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With this development, the COMIRNATY vials can be stored in all 27 European Union (EU) member states at these updated temperatures during the period alternatively to the storage at ultra-low temperatures.
Pfizer noted that this EMA approval is a significant milestone in the vaccine roll-out, as it could aid in vaccine storage in pharmacies which could support inoculations at local practices/doctors’ offices.
Meanwhile, in initial investigations, BioNTech and Fosun have found no safety issues with vaccine batches sent to Hong Kong, China after vaccinations were stopped owing to packaging defects, Bloomberg reported.
Earlier this month, the Israel Ministry of Health (MOH), Pfizer and BioNTech reported real-world evidence showing significantly reduced incidence rates of Covid-19 in fully vaccinated people.