UAE First Country to Both Emergency Authorize and Make GSK & Vir Biotech Monoclonal Antibody Ready Immediately

UAE First Country to Both Emergency Authorize and Make GSK & Vir Biotech Monoclonal Antibody Ready Immediately

Vir Biotechnology and GlaxoSmithKline’s investigational monoclonal antibody product called Sotrovimab (Vir-7831) was authorized today by the UAE’s health ministry given the experimental product’s efficacy treating COVID-19.  The Ministry of Health and Prevention (MoHAP) authorized and licensed the product, making it the very first country in the world to both license and offer the public immediate access. Recently endorsed by the U.S. Food and Drug Administration (FDA), the investigational, single-dose monoclonal antibody is used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients aged 12 and up as long as they weigh in at at least 40kg. 

The Background

This monoclonal antibody was authorized as it evidences positive results targeting SARS-CoV-2 viral testing and demonstrates positive impact for patients facing higher risk for disease progression. That is, the therapy should be used in cases where there are increased risks that the mild-to-moderate COVID-19 patient could see their disease advance to hospitalization or even death, reports the Khaleej Times.

Rational in UAE

UAE’s MoHAP shared that they authorized the use as the drug can reduce the probability of hospitalization for more than 24 hours and deaths by as much as 85% when administered to COVID-19 patients early on. The monoclonal antibody evidences promise targeting variants, including the one in India as demonstrated in preclinical research.

The UAE’s Minister of Health and Prevention Abdul Rahman bin Mohamed Al Owais declared, “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.”

Already, the Ministry has introduced protocols to ensure doctors have guidelines for early use. 

Evidence of Sotrovimab’s clinical efficacy

The FDA granted emergency use authorization to Sotrovimab based on an interim analysis of efficacy and safety data from the Phase 3 Covid-19 Monoclonal antibody Efficacy Trial – Intent to Care Early (COMET-ICE) trial in high-risk adult outpatients.

The interim study results demonstrated an 85 percent reduction in hospitalization for more than 24 hours or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial.

The most common adverse events observed in the sotrovimab treatment group in COMET-ICE were rashes at 2 per cent and diarrhea at one per cent, all of which were graded at mild or moderate.

Adrienne E. Shapiro, M.D., Ph.D., an infectious disease specialist at Fred Hutchinson Cancer Research Center and investigator in the COMET-ICE trial, said, “Monoclonal antibodies like sotrovimab are potentially one of our most effective tools for fighting the coronavirus. While preventive measures, including vaccines, can reduce the total number of cases, sotrovimab is an important treatment option for those who become ill with Covid-19 and are at high risk – allowing them to avoid hospitalization or worse.”

Good News but Also Limitations

One challenge with this class of treatment is that it still requires expensive, administratively cumbersome, in-clinic treatment and narrows the use to a certain class of patient. As TrialSite recently wrote, the next wave of orally available (pill) treatments in the pipeline (Roche, Merck, Pfizer) represent the next big leap in the treatment of COVID along with select generic repurposed drugs, which can dramatically bring down the price points of drugs such as the case with ivermectin in India which is on the national protocol. 

Responses

  1. Thus another reason to keep ivermectin under the radar. No emergency use if there is an alternative medication already on the market that can do the same thing…no money to be made there…no names to be put down in history…