UAE 1st country to approve highly effective, new COVID-19 treatment authorized by FDA for emergency use

The Ministry of Health and Prevention (MoHAP) has approved the emergency use of a highly effective new treatment for COVID-19, becoming the first country in the world to both license and enable immediate patient use after the US Food and Drug Administration (FDA) gave an emergency use authorization to the antibody treatment.

The new treatment, from globally-leading healthcare company GSK, "Sotrovimab (Vir-7831)" offers the prospect of reducing hospitalization for more than 24 hours and fatalities by as much as 85% when administered to patients as an early treatment for COVID-19.

The UAE has authorized the emergency use of Sotrovimab, a monoclonal antibody, for the treatment of patients aged 12 years or older with mild to moderate COVID-19 disease who are at risk of progression to hospitalization or death. In pre-clinical studies, Sotrovimab has demonstrated effectiveness as a monotherapy against widely circulating variants of the disease.

"Such a new qualitative achievement would not have been possible had it not been for the UAE leadership’s keenness to proactively address the pandemic, attract and provide innovative medicines that prove effective and efficient, and adopting them as treatment protocols," said Dr. Abdul Rahman bin Mohammad bin Nasser Al Owais, Minister of Health and Prevention.

"The new medicine will greatly contribute to speeding up the recovery of patients, reducing Covid-19-related deaths and hospitalization period in intensive care units. It will also support the country’s efforts being made to conduct Covid-19 tests and administer vaccines, retaining its leading position among the world's foremost countries, dealing efficiently with the Covid-19 pandemic," the minister said.

"This achievement is yet another breakthrough that crowns the painstaking efforts made by our wise leadership, which spares no effort to harness all capabilities and resources to protect the health of UAE people and safeguard the country’s gains achieved over the course of the past years at all levels," Al Owais added.

He stressed the importance of partnerships between the UAE health sector, international research institutions and the private medical and pharmaceutical sector and relying on science and innovation. This is one of the great lessons learned from the Covid-19 pandemic, in which the UAE has proven its success in facing the largest health crisis in modern history.

"The discovery of innovative solutions and treatments in order to deliver distinct and effective health care services, especially during pandemics, can help governments face health crises more effectively and efficiently, the minister noted.

"From the earliest days of the pandemic. the MOHAP strategy has centred on embracing promising new technologies, including tests. vaccines and treatments in our efforts to subdue COVID-19," said Dr. Mohamed Salim Al Olama, Under-Secretary at Ministry of Health and Prevention.

"We have been pleased to partner with GSK to ensure that critical elements are in place to ensure early access, from licensing and shipments to training and new guidelines for doctors, he noted, adding that new guidelines are in place to guide doctors on appropriate use and how to direct patients to the centres where Sotrovimab will be available.

Al Olama emphasized that the UAE has always been proactive in approving and registering global innovative medicines, according to an innovative mechanism developed to evaluate and approve first-of-its-kind medicines, adding that licensing the innovative treatment ‘Sotrovimab’ comes in implementation of Law No. 8 of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments.

The UAE has become the first country in the world to license and bring GSK treatments into use thanks to the long-established strategic partnership with the globally-leading healthcare company and the confidence in the UAE's global position. This is in addition to the fact that the UAE has a clear vision and firm belief that reaching a radical solution to the pandemic will be through broad international solidarity and cooperation, and enhancing the quality and efficiency of health systems, logistical capabilities and leading global infrastructure.

The new drugs, which have been approved after proving effective in treating the new variants of Coivd-19, will help speed up the recovery of infected people and reduce deaths among Covid-19 patients. It will be a turning point in the ongoing battle against the coronavirus in light of the noticeable progress made by the UAE in providing vaccines and treatments, something which resulted in tangible results including the increase in Covid-19 recoveries and the significant decrease in Covid-19 deaths.

"GSK is committed to bringing our finest scientific advances to patients in the Gut, said Gizern Akalin, Managing-Director and Vice President, GSK Gulf, based in Dubai.

"We are working in close partnership with the MOHAP to ensure that our innovative medicines and vaccines are available to the patients who need them, a mission that has taken on new urgency during the pandemic," Akalin added.

News Source: https://www.wam.ae/en/details/1395302938746