FDA Grants Emergency Authorization For COVID-19 Monoclonal Antibody Treatment
PITTSBURGH (KDKA) -- New treatments will soon be helping Coronavirus patients while scientists race to find a vaccine.
The United States is now allowing its first emergency use of a COVID-19 antibody drug.
According to the pharmaceutical company Eli Lilly, it plans to have 100,000 doses ready to ship in days.
The company wants to have one million doses by the end of the year.
This single antibody treatment must be infused in a hospital or other healthcare setting.
It is the first monoclonal antibody to be authorized for treatment of COVID-19. It's intended to jump start an immune response to the virus.
The FDA's authorization came after studies were published in October. It found the treatment lowered the risk of hospitalization and eased some symptoms.
During a Phase 2 trial, only 1.6% of people given the treatment had symptoms reach a point where they need hospitalization.
With a placebo it was 6.3%.
This comes weeks after a Pittsburgh doctor spoke with KDKA about new evidence suggesting that natural COVID-19 antibodies wane over time.
This also comes as Pfizer announced its vaccine trials are showing a 90% effectiveness rate, which a local infectious disease expert called 'encouraging.'
The FDA did not license the drug, but granted it emergency use -- a fast track approval process.
The drug still must be shown to be safe and effective.
