The European Medicines Agency (EMA) included Celltrion’s antibody treatment Regkirona (regdanvimab) in the list of critical medicines for Covid-19.
EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of critical drugs for the Covid-19 public health emergency on Tuesday, according to the Korea Biotechnology Industry Organization (Korea BIO).
The list includes five Covid-19 vaccines and nine treatments authorized by the EU to prevent or treat the infection. The EMA said it would closely monitor the supply and demand of those vaccines and treatments to identify and manage potential or actual shortages.
The list of the vaccines and treatments for Covid-19 are Pfizer’s Comirnaty, Dexamethasone-containing medicines, Roche’s RoActemra, Janssen’s Jcovden, AstraZeneca’s Evusheld, Roche’s Ronapreve, Novavax’s Nuvaxovid, Sobi’s Kineret, Gilead’s Veklury, Moderna’s Spikevax, Pfizer’s Paxlovid, GSK’s Xevudy, AstraZeneca’s Vaxzevria, and Celltrion’s Regkirona.
Celltrion’s Regkirona is the only Korean medicine on the list.
Marketing authorization holders (MAHs) of these drugs should regularly update EMA with relevant information, including data on shortages, available stocks, and forecasts of supply and demand, according to EMA.
“This will enable the MSSG to recommend and coordinate appropriate EU-level actions to the European Commission and the EU Member States to prevent or mitigate potential or actual shortages of critical medicines to safeguard public health,” EMA said.
The MSSG was established to help EMA prepare for public health emergencies under a law enacted on January 31, 2022 (Regulation 2022/123). By enhancing the EMA’s role in crisis preparedness and management of medicines and medical devices, the MSSG can ensure a robust response to major events or public health emergencies and urgent coordinate actions on the supply of medicines within the EU.