Celltrion's COVID-19 Treatment Prepares for Full-Scale Entry into Middle East Region
Usage Approval Applications Submitted to Major Pan-Arab Countries Including Saudi, UAE, and Iraq
[Asia Economy Reporter Kim Ji-hee] Celltrion announced on the 11th that the approval process for the use of its COVID-19 antibody treatment, Rekkeulona, in major countries of the Arab League has officially begun.
Celltrion recently completed the submission for approval of Rekkeulona to regulatory authorities in key Arab League countries including Saudi Arabia, the United Arab Emirates (UAE), Jordan, Iraq, and Morocco. The company plans to accelerate the approval process in the Middle East region to take the lead in preventing the spread of COVID-19 in Arab League countries. It also announced a contract to sequentially supply 100,000 vials of Rekkeulona to a Pakistani state-owned company as the first supply agreement in the region.
In early February this year, Celltrion received conditional marketing authorization for Rekkeulona from the Ministry of Food and Drug Safety. Currently, the European Medicines Agency (EMA) is conducting an evaluation of Rekkeulona’s safety and efficacy through a rolling review, and in March, European countries urgently needing COVID-19 treatments issued a recommendation allowing the use of Rekkeulona prior to formal marketing authorization.
On the 6th, the European Commission announced plans to approve the sale of three COVID-19 treatments by October and to select the five most promising COVID-19 treatments by June to establish joint procurement contracts for European governments by the end of the year. Celltrion expects that ongoing discussions regarding European approval and supply will accelerate further.
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A Celltrion official stated, “We have completed the submission for approval of Rekkeulona in major Middle Eastern countries and are accelerating the approval process in Arab League countries including Asia and North Africa. Considering the limited production capacity of antibody treatments, we plan to prioritize supplying Rekkeulona to countries with medical infrastructure capable of early diagnosis and treatment to prevent severe or fatal cases.”
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