ANGLO-SwedeN pharmaceutical company AstraZeneca introduced its breakthrough drug that showed impressive results in both prevention and treatment of Covid-19.
The new drug, called AZD7442, combines two fully human monoclonal antibodies, described as Long-Acting Antibody (LAAB,) that can be administered via intramuscular intervention.
The drug underwent a comprehensive clinical trial that dealt with both prevention under the PROVENT trial, and treatment, called TACKLE.
Dr. Hugh Montgomery, Professor of Intensive Care Medicine at University College London, said that in Provent, for the first three months of median follow-up, antibodies reduced severe disease or death by 77 percent compared to placebo.
Antibody treatment
On the other hand, after six months, they found an 83-percent reduction in risk of Covid-19 with only one dose, showing that the antibody treatment does work well, and the impact was sustained throughout the six-month period.
“The good news is that we really do prevent severe disease or death and was seen as a highly safe mode of intervention,” Dr. Montgomery explained.
As for the Tackle treatment trial, where he was the principal investigator, Dr. Montgomery said the trial showed the importance of tackling the disease at an early stage. For treatment done three days at the onset of Covid-like symptoms, he said the drug displayed an 88 percent reduced risk of severe disease or death and was very well tolerated within the trial group.
“For people with ailments that render their immune system less effective like cancer, the immunocompromised, those undergoing dialysis or underwent transplantation, those with autoimmune disease, those who need to protect themselves, this intervention is so exciting,” Dr. Montgomery said during his presentation.
EUA
Right now, the drug is waiting the issuance of an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA), which may come in the next few weeks, says Iskra Reic, executive vice president, Vaccine and Immune Therapies Unit of AstraZeneca.
She said rolling reviews are also ongoing in the European Medicines Agency (EMA), the UK Health Security Agency (UKHSA) and regulators in other countries. She revealed that Bahrain became the first country to issue an EUA just last week.
Reic likewise echoed Dr. Montgomery’s statement, saying that AZD7442 has presented itself as an important solution being the only LAAB therapy that demonstrated benefits in both prevention and treatment of Covid-19 during the Phase 3 trials. “The trials were done to see how the vulnerable population will react because they are the ones that really need the solution,” Reic said.
With this development, Reic reiterated the company’s full commitment in its fight against Covid-19. She mentioned that the company is also looking at making the price scheme affordable “because at the end of the day our premium objective is to make sure that patients who need protection and treatment against Covid-19 will have access to it.”
With AstraZeneca’s experience in developing monoclonal antibodies with its global partners and signed supply agreements with other countries, Reic assured that the company will be able to cover the demand.