FDA grants emergency use of Regeneron antibody drug

WHAT YOU NEED TO KNOW:

• The Food and Drug Administration (FDA) on Saturday authorized the emergency use of the Regeneron antibody drug to help COVID-19 patients in their illness battle.
• US health officials permitted the use of the drug to expedite its availability as the country’s coronavirus cases continue to grow.
• The White House called the FDA’s decision a victory for the Trump administration in its fight against COVID-19.

On Saturday, US health authorities granted the emergency use of the antibody-drug developed by Regeneron Pharmaceuticals to aid the immune system in its fight against the coronavirus. The drug was administered to President Donald Trump when he contracted COVID-19 last month.

The Regeneron-based drug was allowed by the Food and Drug Administration (FDA) to be used by patients with mild-to-moderate symptoms to avoid hospitalization and mitigate the severeness of the disease. In this time of health crisis, the agency regulators permitted the drug use to expedite its availability to the public.

As a one-time IV treatment, the said medicine can be injected in adults and children who are at high risk of serious illness linked to other medical conditions or age. Children should be 12 and above and weighing at least 40 kgs (about 88 pounds) to qualify.

With the permission of emergency use, the drug could be administered to patients while research is ongoing to scientifically validate its efficacy and safety. The FDA said that initial results showed that Regeneron drug has minimized hospitalization rates, especially for high-risk patients.

Through the federal government allocation scheme, the pharmaceutical company said that initial doses could be availed by around 300,000 patients without charge. Fees may only be applied for the IV administration service.

With the continuous surge of new infections across the country, the initial supplies would likely become obsolete as public health professionals warned of the upcoming ‘dark winter.’

According to White House spokesperson Michael Bars, it was a victory for the Trump administration “to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans.” 

The emergency grant serves as a temporary approval during the coronavirus pandemic. Should Regeneron wish to get permanent approval, it will have to lay down the medical researches certifying the safety and efficacy of the drug.

The Regeneron drug aims to boost its effectiveness of fighting the virus through the combination of two antibodies that would shield the body against the virus.

Source: AOL.com