Monoclonal antibody to treat early Covid-19 infections has been cleared by the United States Food and Drug Administration, said Vir Biotechnology Inc. and GlaxoSmithKline PLC,
The drug, called sotrovimab, is the third antibody drug authorized to treat patients at the onset of disease who are at high risk of developing severe cases.
The authorization of a new Covid-19 drug at a time when half of the American population has received at least one dose of the vaccine is a reminder of the massive investments made by governments and drugmakers last year that could take years to bear fruit, if ever. .
Vir and Glaxo are betting the world will fight Covid-19 for years to come, even on a very small scale, due to new virus variants and uneven vaccination rates.
“The rapid pace of Covid-19 vaccinations in the United States is encouraging, but despite these aggressive efforts, there is still a need to help prevent infected patients from developing complications,” said Dr Hal Barron, director scientist from Glaxo.
On the vaccine front, companies such as Glaxo and its partner Sanofi SA continue to push costly development programs forward in hopes of competing with market leaders such as Pfizer Inc. Glaxo and Sanofi recently launched a study of phase 3 of their Covid-19 vaccine with a goal of obtaining regulatory approval in the fourth quarter.
Vir, a relatively small company with no approved products, will have to meet the high expectations of analysts and investors. Vir shares have climbed 70.9% so far this year and have risen by more than a third in the past 12 months.
Cowen & Co. analysts forecast sotrovimab sales of $ 300 million this year and $ 500 million in 2022. Vir research and development spending in the first quarter more than doubled to $ 134.9 million. dollars compared to the same period last year.
“We’ve put a lot of effort into getting this antibody to where it is now; we have made big financial commitments for a company of our size, ”said George Scangos, CEO of Vir, in an interview.
It is unclear what role the drug will play in the short term in the United States, where new infections are on the decline and there remains a glut of unused antibody drugs manufactured by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc.
So far, the US government has purchased antibody drugs directly from manufacturers and made them available to patients free of charge through hospitals and clinics.
Unlike Lilly and Regeneron, Vir and Glaxo do not have a contract with the US government to purchase their drug. Without a pre-purchase agreement, companies will have to sell the drug through existing trade channels to hospitals and healthcare providers while competing with essentially free treatments.
Companies will also need to persuade health insurers to cover the drug when patients can receive similar treatments free of charge. Vir and Glaxo are in talks with health insurers to cover the drug, but have yet to enter into a contract, Dr Scangos said.
Dr Scangos acknowledged the business challenges of launching the drug, but said he was encouraged by insurers’ comments on sotrovimab, including its ability to work against new variants of the virus.
He said the drug’s price would likely be similar to what the government paid for the anti-Regeneron and Lilly antibodies, ranging from $ 1,250 per dose to $ 2,100 per dose.
Vir and Glaxo have a few hundred thousand doses of the drug available and plan to manufacture a total of two million doses this year, Dr Scangos said. The companies are in talks to sell the drug in Europe and Asia, as well as India, South Africa and Brazil, he said.
The European Union’s medicines regulator said earlier this month that sotrovimab can be used to treat Covid-19, opening the door for individual member states to authorize it for emergency use.
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Vir and Glaxo said they developed sotrovimab to fight new variants of the coronavirus that emerge over time. In April, the FDA revoked the authorization of Lilly’s bamlanivimab alone to treat Covid-19 due to the increasing prevalence of drug-resistant variants.
In most cases, Lilly’s medicine can still be used in combination with another Lilly’s antibody called etesevimab. In May, the Department of Health and Human Services said it would stop distributing the combined drug in Illinois and Massachusetts due to an increase in the so-called Brazilian variant in the state.
Regeneron’s drug, named REGEN-COV, is a combination of two antibodies and has so far been shown to be effective against the main variants that have emerged.
Monoclonal antibodies are modeled on the natural antibodies produced by the immune system to fight against the new coronavirus. Medicines require a single infusion. In the clinical trials of Lilly and Regeneron, the drugs reduced the risk of hospitalization or death by 70%.
The drugs have not been adopted as widely as public health officials had hoped, in part because hospitals were slow to set up infusion sites. There has also been a lack of awareness of treatments, which drug makers have sought to combat through commercialization.
By mid-May, Lilly and Regeneron had delivered nearly a million doses of antibodies to the government, 49% of which have been used by patients so far, according to HHS.
Write to Joseph Walker at [email protected]
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