October 4, 2022

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FDA revoked emergency use authorization for GSK/Vir COVID-19 antibody therapy

FDA revoked emergency use authorization for GSK/Vir COVID-19 antibody therapy



 

FDA revoked emergency use authorization for GSK/Vir COVID-19 antibody therapy

The U.S. FDA recently announced that the proportion of COVID-19 infections caused by a new variant of Omicron BA.  to treat COVID-19 anywhere in the United States.

 

The proportion of COVID-19 cases caused by the Omicron BA.2 variant virus has exceeded 50 in all U.S. Health and Human Services (HHS) regions, according to estimates from the Centers for Disease Control and Prevention (CDC) on April 5, 2022 %, while data in a health care provider fact sheet issued by the U.S. Food and Drug Administration showed that previously authorized doses of Xevudy were unlikely to be effective against the BA.2 variant of the virus.

 

FDA revoked emergency use authorization for GSK/Vir COVID-19 antibody therapy

 

In this regard, the US FDA will continue to monitor the situation of the BA.2 variant virus nationwide and provide follow-up communication measures in a timely manner.

The FDA recommends that healthcare providers use alternative therapies such as Paxlovid, Veklury, bebtelovimab, and molnupiravir, all of which have been previously authorized or approved for the treatment of mild to moderate disease at high risk for progression to severe disease, including hospitalization or death patients with COVID-19.

 

It is worth noting that the FDA’s conclusion that the therapy is almost ineffective against the BA.2 variant virus is quite different from the trial data just released by GlaxoSmithKline in February this year, when GlaxoSmithKline and Vir announced monoclonal antibody therapy.

Xevudy is effective against Omicron BA.2 subspecies virus. GlaxoSmithKline said at the time that based on pseudoviruses and extensive pharmacokinetic data, the 500mg dose of sotrovimab was sufficient to maintain neutralizing activity against Omicron BA.2 subspecies.

In addition, Xevudy can treat patients with mild to moderate COVID-19 79% lower risk of hospitalization and death.

 

As of April 5, 2022, Xevudy retains therapeutic authorization in Europe. During the COVID-19 pandemic, when trial data show that certain antibody products are no longer effective against the virus, or new variants of the virus can prompt regulators to pull off previously approved treatments.

It is reported that the U.S. FDA had previously announced that it would stop using Xevudy in several states in the northeastern United States, and later expanded the scope of Xevudy’s restrictions to about half of the country, and is currently banned in the United States.

 

For GlaxoSmithKline and Vir, the U.S. FDA’s suspension of Xevudy’s nationwide use means that future sales of the therapy will be severely hit. In 2021, Xevudy’s sales revenue will reach £958 million ($1.26 billion).

As for 2022, GlaxoSmithKline had previously been optimistic that Xevudy could generate 1.4 billion pounds ($1.83 billion) in revenue, but due to this negative factor, its actual sales may be difficult to meet this expectation.

 

It’s worth noting that GSK and Vir aren’t the only biopharma companies that have been frustrated by the uncertainties of the pandemic. Antibody drugs from Eli Lilly and Regeneron were also put on hold for the same reason, according to U.S. FDA records.

Meanwhile, antiviral drugs from Merck and Pfizer are still available, and AstraZeneca’s Evusheld has also been approved by the US FDA for pre-exposure prophylaxis in people with weakened immune systems or who cannot be vaccinated against COVID-19.

 

 

 

 

 

Reference:

1. FDA: Sotrovimab No Longer Authorized to Treat COVID-19 in Any US Region

2. GSK, Vir’s COVID antibody put on ice as BA.2 subvariant takes hold

FDA revoked emergency use authorization for GSK/Vir COVID-19 antibody therapy

(source:internet, reference only)


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