Frankfurt In the fight against the Covid pandemic, new therapy options are giving additional hope in addition to the vaccination campaigns. Several drugs have been on the market since December. Expectations rest primarily on two pills from Pfizer and Merck & Co, but also on new antibody therapies from Astra-Zeneca, Glaxo-Smithkline and Eli Lilly.
The growing demand for drugs is likely to bring manufacturers additional billions in sales this year: Overall, the previously planned sales of Covid drugs for 2022 will add up to more than $32 billion compared to around $18 billion in the previous year.
Thanks to the high vaccination rates, most Covid diseases are currently associated with relatively mild courses, but most doctors also see a longer-term need for therapies. “After the omicron wave, Sars-CoV-2 will certainly not go away. We will see an increase in the number of Covid-19 cases again by winter at the latest,” says Christoph Spinner, infectiologist and pandemic officer at the Technical University of Munich Clinic.
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The virus will therefore continue to pose a high risk, especially for people who are particularly at risk from previous illnesses. “In this respect, there will also be a clear need for Covid-19 therapies in the future,” Spinner is convinced.
A total of eight active ingredients specifically targeting Covid have been approved in Europe and the USA or are available as part of special national approvals. These include five antibody products that can intercept the Sars-CoV-2 virus in the bloodstream and three antiviral agents that interfere with the pathogen’s replication process.
These include the drug Veklury (remdesivir) from Gilead, which has been available since 2020, and the drugs Paxlovid from Pfizer and Lagevrio (with the active ingredient molnupiravir) from Merck & Co.
In addition, anti-inflammatory agents such as cortisone are used to treat seriously ill Covid patients. However, these are all drugs that have been on the market for a long time and are otherwise used, for example, in rheumatism therapy.
For the first time tablets against the Covid 19 disease
There is currently a real upheaval in Covid therapy and in the market: On the one hand, Paxlovid and Molnupiravir are drugs that can be taken as tablets for the first time. This tends to make treatment easier and accessible to a much broader group of patients. The antibodies that have been available so far have to be administered primarily as a fusion and are therefore hardly suitable for mass use.
Paxlovid in particular, which showed a high efficiency of almost 90 percent in a clinical study and apparently works against all virus mutations, is considered the clear favorite among the new oral Covid drugs. Pfizer has so far agreed supply contracts with various countries, including Germany, for a total volume of more than 30 million packs and intends to expand its production capacities to up to 120 million packs by 2022.
On the other hand, the rapid spread of the omicron variant is also forcing a change in the use of antibodies. Because some of these products, including in particular the drug Regen-Cov/Ronapreve from Roche/Regeneron and the antibody combination Bamlanivab/Etesevimab from Eli Lilly, are no longer effective against this mutation.
In the USA, the FDA recently revoked the emergency use approval for the two active ingredients in all regions where the omicron variant is dominant. But that is now the case almost everywhere in North America and Europe.
On the other hand, the US authorities granted emergency approval at the weekend for a newly developed antibody from the companies Eli Lilly and Abcellera, which in comparative studies showed a better effect against diseases with the omicron variant and reduced the risk of hospitalization.
Things are currently looking good for the newer antibody products, which only received their first approvals in summer and autumn 2021. These include the drug Evusheld from Astra-Zeneca and the antibody Xevudy (Sotrovimab) from Glaxo-Smithkline (GSK), which has also been approved in Europe since December.
According to medical experts, Xevudy in particular has shown very good effectiveness against Omikron in previous studies. In the clinical studies with people at risk who were infected with the original virus or the alpha variant, the drug reduced the risk of death or hospitalization by more than 80 percent. At the same time, laboratory analyzes showed that the antibody also acts against omicron.
The active ingredient in Astra-Zeneca is considered by experts to be slightly weaker, but its effects tend to last longer. It also has a chance of being approved as a prophylactic agent. In the USA, the drug has been approved since September, in the European Union the process has been running at the Ema since October in the so-called rolling process.
How broadly the new funds will actually be used remains difficult to estimate for the time being. A key challenge with both oral medications and antibodies is that they have to be administered as early as possible – within a week of the onset of the disease – in order to be fully effective.
This time window is often missed, especially for people who do not belong to a special risk group. “The normal patient often doesn’t even think about going to the doctor or the clinic when they get infected,” observes Oliver Witzke, Director of the Clinic for Infectious Diseases at the University Hospital in Essen: “They only become aware when they can’t breathe anymore, then it is too late to initiate antiviral therapies.”
In addition, from his point of view, the intersection between outpatient and inpatient care has not yet been optimally structured. The importance of early treatment has not yet been sufficiently understood by many doctors.
Drugs should not be used hastily in vaccinated people
On the other hand, doctors agree that it would also be completely unreasonable to basically fight any Covid infection with antiviral agents, since the vaccines offer a very high level of protection against serious illnesses for most people. It is therefore considered rather nonsensical to use these drugs in vaccinated people without risk factors.
Doctor Spinner also points out that the drugs in the clinical studies were predominantly tested on unvaccinated people and there is therefore no hard evidence as to what advantages they could still offer to vaccinated people. “We don’t know for sure to what extent these individuals will benefit from treatment.”
The same applies to the question of how the fields of application for the various classes of active ingredients will be defined in the future. Comparative studies between the various drugs have not yet been carried out and are not in sight for the time being.
Irrespective of the new oral agents, Spinner also sees a very important role for the antibodies. He points out that the clinical evidence for this product group is more robust overall. The trend will probably be that people with severe immunodeficiencies will continue to be treated with neutralizing antibodies.
“For unvaccinated people with common risk factors such as diabetes, high blood pressure or obesity, oral medications are more likely to be considered,” says Spinner: “However, the boundary conditions play a decisive role in the selection.”
Paxlovid, for example, interacts with various other medications, including the commonly prescribed anticoagulants. For some of the typical high-risk patients, the remedy may not be an option.
Therefore, the competitor product Lagevrio from Merck & Co should continue to play a role, although it showed a lower effectiveness of only 50 percent in clinical studies and was associated with the risk of mutations in the human genome.
The US group promises sales of six billion dollars for its funds. However, the sum of the previously planned sales of Covid drugs of 32 billion dollars could even increase significantly.
Pfizer in particular has already signaled that its forecast could be corrected significantly upwards over the course of the year. The group says it is in talks with more than 100 governments about additional supply contracts.
More: Corona drugs and their effects – an overview