By Joseph Walker and Peter Loftus
President Trump's endorsement of an experimental Covid-19 drug
from Regeneron Pharmaceuticals Inc. has raised expectations for a
type of medicine that could be authorized for public use within
weeks or even days.
Regeneron is racing against rival Eli Lilly & Co. to bring
the first monoclonal antibody drug on the market to treat Covid-19
patients who aren't sick enough to be hospitalized. Both companies
said Wednesday they had asked the U.S. Food and Drug Administration
to authorize use, and they had already made tens of thousands of
doses for patients.
If greenlighted, the shots would begin to fill a big hole in the
Covid-19 medicine chest for treatment of early and less-severe
cases. After more testing, they could offer temporary protection
against infections until vaccines arrive. But supply is unlikely to
meet demand until next year at the earliest.
Monoclonal antibodies, which are also used to treat cancer and
other diseases, take a page from the body's own soldiers for
fighting pathogens. Both Lilly and Regeneron researchers derived
their drugs from naturally occurring Covid-19 antibodies.
Each of the companies has released encouraging data from
early-stage clinical trials showing their drugs helped reduce
coronavirus levels and improve symptoms in patients not sick enough
to be hospitalized. Lilly and Regeneron have already started
studies to see if their antibody drugs can prevent Covid-19.
Given the urgent need, the companies asked the FDA to use a
special review process reserved for emergencies such as pandemics
and authorize use before the therapies have finished all the stages
of testing normally required for approval.
The FDA could issue the go-ahead for the monoclonal antibody
drugs as soon as Friday, SVB Leerink analyst Geoffrey Porges said.
The agency could feel comfortable making a quick decision, he said,
because it is already familiar with the way antibody drugs work,
having approved many of them over the years to treat other
diseases.
The FDA declined to comment about its review of the applications
or the timing of a decision.
The agency has granted emergency-use authorizations for two
therapies for hospitalized Covid-19 patients, the antiviral
remdesivir from Gilead Sciences Inc. and antibody-rich convalescent
plasma taken from recovered coronavirus patients. An antibody drug
could be the next agent to be permitted for use.
Last Friday, Mr. Trump was given a high dose of Regeneron's
drug, code-named REGN-COV2, under a program that allows patients to
take experimental drugs outside of clinical trials. He was later
given the antiviral drug remdesivir, which the FDA authorized in
May, and the already approved steroid dexamethasone.
Mr. Trump's doctors have said he is symptom free. In a video
released late Wednesday, the president attributed his return to
health to Regeneron's drug.
"They gave me Regeneron, and it was like, unbelievable. I felt
good immediately," he said. Independent doctors have cautioned
against singling out any specific factor for Mr. Trump's feeling
better, or even concluding he has recovered, given the
unpredictable course of the disease and various care he
received.
"The president's team of medical consultants and advisers all
thought that for a person in his position, they saw the
benefit-risk equation, and they thought that this might be a
reasonable thing to do," George Yancopoulos, Regeneron president
and chief scientific officer, said in a recent interview. "I think
it means that there's going to be a lot of other people who come to
that conclusion."
Mr. Trump also said he encouraged the authorization of antibody
drugs and would make sure patients wouldn't have to pay for
them.
Companies normally don't request the FDA's clearance of a drug
until they have discussed the matter with the agency and believe
they have the kind of data that could secure a regulatory green
light. The agency will, nevertheless, sometimes refuse to approve a
drug after reviewing the application, or ask for more testing.
Administration officials could take the reins from the agency,
as they did in 2011 when Health and Human Services Secretary
Kathleen Sebelius overruled an FDA decision to make an emergency
contraceptive broadly available, including to young teenagers.
Regeneron and Lilly said they didn't know how long the FDA would
take to review the requests for authorization. Lilly has been
working with FDA reviewers for several months at a fast pace,
company executives said, and they expect that clip to continue.
Both companies said they have been making doses. Regeneron said
it has enough supply to treat 50,000 patients right now, and for a
total 300,000 patients within a few months. Lilly said it would
have 100,000 doses by the end of this month, and as many as a
million by year's end.
The supply probably won't be enough to give the drugs to
everyone who could take it. More than 44,000 Americans were
diagnosed with Covid-19 on average each day over the past week,
according to Nephron Research, a health-care-focused investment
research firm.
"We just know that supply isn't going to meet the needs of
people around the world" initially, Lilly's chief scientific
officer, Daniel Skovronsky, said in an interview. Lilly executives
said the federal government would decide who should get initial
supplies, but the company suggested people over age 65 years or who
are obese should be candidates because they are at higher risk of
worsening to severe Covid-19.
Regeneron would try to make sure its drug would be "distributed
fairly and equitably to the patients most in need" if it is
authorized, a company spokeswoman said.
To boost production, Lilly in September signed a collaboration
with Amgen Inc. in September to help manufacture Lilly antibody
therapies. Roche Holding AG agreed in August to help make and
distribute Regeneron's antibody product.
Manufacturing monoclonal antibodies is more complicated,
expensive and time-consuming than making traditional pills.
Antibody drugs are grown in living cells fed various nutrients to
cultivate their development. Regeneron said it takes two months to
make its Covid-19 drug.
Neither Lilly nor Regeneron has given a price for their
therapies, though both have said they expect patients will be able
to get the drugs with no or very low out-of-pocket costs. Regeneron
said the U.S. government would distribute the first 300,000 doses
of its drug free, because it helped fund the drug's
development.
Antibody drugs for cancer, rheumatoid arthritis and other
diseases can cost tens of thousands of dollars a year or more.
Lilly Chief Executive David Ricks said in a call with reporters
Wednesday that the company would consider the special situation
created by the pandemic in pricing its Covid-19 drug, though it
must also account for its heavy investment.
It will be hard for the drugmakers to set too high a price, SVB
Leerink's Mr. Porges said, because most patients who get the drug
probably wouldn't have developed a severe case anyway.
"If you treat 100 individuals with an expensive IV infusion to
keep five from going into the hospital, it's not a very compelling
value proposition," he said.
Mr. Trump's endorsement of the antibody drugs, and his promise
to make them available free, will likely cause many infected
patients to seek prescriptions even if they aren't showing any
symptoms, Mr. Porges said. He expects insurers to triage patients
by setting criteria for who can receive the medications, such as
whether they have symptoms and risk factors.
AstraZeneca PLC said Friday that it will start testing its
monoclonal antibody drug in a Phase 3, or final-stage, clinical
trials in the coming weeks. The drug, code-named AZD7442, combines
two antibodies derived from patients who recovered after being
infected by the new coronavirus.
AstraZeneca said one study will enroll 5,000 healthy volunteers
to test if the drug can prevent infection for up to one year; the
second study will test the drug's effectiveness in preventing or
ameliorating symptoms in 1,100 patients who have been exposed to
the virus.
The U.S. government is supporting the development of
AstraZeneca's drug with $486 million. The U.S. is entitled to
receive up to 100,000 doses of the drug toward the end of 2020, and
the option to acquire an additional one million doses in 2021 under
a separate agreement, AstraZeneca said.
--Thomas M. Burton contributed to this article.
Write to Joseph Walker at joseph.walker@wsj.com and Peter Loftus
at peter.loftus@wsj.com
(END) Dow Jones Newswires
October 09, 2020 17:51 ET (21:51 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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