More than 30 people tested positive for COVID-19 after attending the Supreme Court nomination event for Amy Coney Barrett at the White House on Sept. 26. |
Former New Jersey Gov. Chris Christie — a close Republican ally of President Donald Trump — revealed he was treated for COVID-19 with Eli Lilly and Co.'s experimental antibody treatment, becoming the latest person with VIP status to obtain access to a drug out of reach for most Americans.
Christie said he was also treated with Gilead Sciences Inc.'s antiviral remdesivir.
The former governor tweeted Oct. 3 that he had checked himself into a New Jersey hospital after testing positive for COVID-19.
Christie was among over 30 people who acquired COVID-19 after attending Trump's Sept. 26 White House announcement revealing his Supreme Court nominee, Amy Coney Barrett — an event U.S. National Institute of Allergy and Infectious Diseases Director Anthony Fauci deemed a "superspreader" of the virus.
Trump tested positive for COVID-19 on Oct. 1 and within hours, received an infusion of Regeneron Pharmaceuticals Inc.'s experimental antibody treatment REGN-COV2.
Trump was among only a handful of people to obtain REGN-COV2 under the U.S. Food and Drug Administration's expanded access program — also known as compassionate use — even though Regeneron has received several other requests for the product, according to the company's top two executives.
Neither Trump nor Christie wore masks at the Sept. 26 event, where most in attendance also did not wear face coverings and did not practice social distancing.
Christie tweeted Oct. 10 that he had been released from the hospital.
In an Oct. 15 statement posted on Twitter by a reporter at The New York Times, Christie said he had been treated in the intensive care unit for seven days, where he received Lilly's and Gilead's experimental drugs. Christie also said he and the other people at the Sept. 26 event were wrong for not wearing masks and failing to social distance.
'Exceptional circumstances'
Lilly is pursuing development of a single antibody drug, bamlanivimab, also known as LYCoV555, and a combination of that medicine and another antibody, etesevimab, or LY-CoV016, to treat COVID-19.
On Oct. 13, Lilly paused its phase 3 trial testing LYCoV555 in combination with remdesivir in hospitalized patients after an unknown safety issue arose. The company's other studies of LYCoV555 and LY-CoV016 are continuing.
Christie said he was treated with Lilly's "antibody cocktail."
Lilly declined to comment specifically on how Christie obtained access to the company's experimental antibody treatment and what criteria he met to receive the therapy.
A spokesperson said the company considers individual patient expanded access for its antibody therapy on a case-by-case basis.
"In exceptional circumstances Lilly may support expanded access to patients — at the request of their physician — who meet predetermined clinical criteria and are unable to participate in a clinical trial," Dani Barnhizer told S&P Global Market Intelligence in an emailed response to questions.
She declined to state the criteria the company used to determine what circumstances qualified as "exceptional."
A number of bioethicists have raised concerns about the standards Lilly and Regeneron are using to provide access to the limited doses of their experimental antibody treatments.
Regeneron said it has 50,000 doses of REGN-COV2 available and may have 300,000 by the end of the year. Lilly said it expects to have 100,000 doses of LY-CoV555 ready sometime in October and 1 million possibly in the fourth quarter. It said it also anticipates having 50,000 doses of its combination treatment available in the fourth quarter.
The U.S. government has purchased up to 300,000 doses of Regeneron's REGN-COV2 under a $450 million contract and last week signed a $486 million deal with AstraZeneca PLC for its antibody drug AZD 7442. AstraZeneca estimated it may have 100,000 doses by December.
But neither the government nor the companies have revealed a plan for equitably allocating the relatively scarce doses of the experimental COVID-19 monoclonal antibody therapies if the products are cleared for the U.S. market.