Trump’s ‘miracle’ coronavirus treatment to be shipped IMMEDIATELY as FDA grants approval in second Covid breakthrough
A DRUG that President Donald Trump praised for treating coronavirus was approved by the U.S. Food and Drug Administration, marking the second major Covid breakthrough on Monday.
With the FDA’s emergency use authorization, Eli Lilly and Co's experimental Covid-19 antibody treatment Bamlanivimab will be shipped immediately for use for patients with mild to moderate symptoms who are not hospitalized and are over 65 years old or have chronic medical conditions.
Eli Lilly and Co’s antibody may also be used on pediatric patients over 12 years old, but is not authorized for coronavirus patients in hospitals or those needing oxygen therapy as it could worsen their condition, according to the FDA.
The government sponsored a study using the antibody on hospitalized coronavirus patients but halted it after their condition did not appear to improve.
Eli Lilly and Co’s antibody is similar to the Regeneron antibody treatment that Trump received at Walter Reed National Military Medical Center when he was diagnosed with Covid-19 in October.
Earlier on Monday, pharmaceutical giant that interim findings from its vaccine clinical trial came back showing a 90 percent efficacy, exceeding expectations.
Pfizer CEO Albert Bourla said the vaccine “will be available for free to all American citizens."
Both Trump and President-elect Joe Biden hailed the news that a coronavirus vaccine could be only weeks away.
But Trump on Monday night accused the FDA and Democrats of wanting to hold off progress on developing a vaccine until after the Nov. 3 election.
“The @US_FDA and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later–As I’ve said all along!” the president .
Vaccine makers are expected to ask the FDA for emergency use authorization later this month.
The two breakthroughs in battle against the virus came as the United States passed 10 million cases, far more than any other country.
The FDA stated that it granted emergency use authorization for Eli Lilly and Co's antibody because clinical trials demonstrated that the treatment lowered the need for high-risk patients to be admitted to hospitals.
Eli Lilly and Co aims to distribute up to one million doses of its antibody treatment in the fourth quarter.
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The Indianapolis-based drugmaker and the US government reached a $1,250 per dose deal, and the antibody will be sold to other countries.
Shares for Eli Lilly and Co rose 3.6 percent after hours from $142.33 in regular trading.
The company is seeking FDA authorization for a two-antibody cocktail which is expected to be even more effective against the virus.