A tablet raises hopes (nd current)

In Covid-19 intensive care units like here in Stuttgart, blood thinners and cortisone preparations such as dexamethasone are used.

Photo: dpa / Marijan Murat

So far, many studies on new active ingredients against Covid-19 have been disappointing. went out. Existing drugs that promise effects in combating Covid-19 also did not meet expectations. Now there are several new candidates who are raising hopes.

Merck’s molnupiravir is at the forefront here. According to the US manufacturer, the antiviral reduces the number of hospital stays by half in those infected with an increased risk of severe disease. Additional advantage: the drug is available as a tablet. Oral administration relieves the burden on healthcare. Other agents such as remdesivir or monoclonal antibodies, which are also used against Covid-19, have to be injected directly into the blood. If this is most effective in the early stages of the disease, it involves a lot of effort.

According to the manufacturer, in a study with 775 corona patients with mild to moderate symptoms in the placebo group, 14.1 percent of the cases had to go to hospital within 29 days or had died. In the verum group that is treated with the drug, that was 7.3 percent, including no deaths. The subjects exhibited at least one risk factor for a severe course of the disease. These results even justified the fact that the study could be discontinued on the recommendation of external experts: It is not ethically justifiable to continue treating patients with placebo only if there is a clear benefit from the therapy.

Molnupiravir is a nucleoside analogue. This class of active ingredients is used against viruses and in cancer therapy. Molnupiravir was already being traded as an influenza drug in 2019, and it also stopped other viruses from multiplying. Nucleosides are the building blocks of RNA and DNA, the carriers of genetic information. Nucleoside analogs imitate these and thus hinder the replication of viruses. In the case of molnupiravir, an altered viral RNA is duplicated and creates mutations that ultimately make the genetic material illegible. Ultimately, however, these mechanisms could also be harmful: As early as 2020, scientists warned that the active substance would disrupt the human genome. So far, however, there have only been indications of this in cell cultures. In animal experiments, even high doses had not caused any damage, Merck reported in the spring. The problem, which has not been conclusively clarified, could lead to molnupiravir only being approved for people at high risk of a severe course of Covid-19.

Merck has now applied for an emergency approval for molnupiravir in the United States. In view of the “urgency” in the fight against the pandemic, his company submitted such an application to the FDA ten days after receiving the data from the clinical phase 3 study, according to Merck CEO Robert Davis. He announced further applications in other countries.

Merck is expected to charge $ 700 for five days of molnupiravir treatment. A new independent study from Harvard University estimates the affordable generic price for a treatment at $ 20. According to the organization Médecins Sans Frontières, Indian generic drug manufacturers could likely bring the drug to the market for less than $ 15 after an emergency approval in India – as it is not yet patented there. From a purely technical point of view, it would be relatively easy to produce. This indicates a new area of ​​conflict in the global distribution of medication, especially since in this case use would be easy to organize even in countries without high-tech healthcare.

Eight drugs for Covid therapy are at various stages in the approval process at the EU drug authority EMA, including four antibody preparations that are already in use in Germany for mild disease. Monoclonal antibodies are made in the laboratory. They are usually quite expensive. In the last few days in particular, the British-Swedish pharmaceutical company Astrazeneca expressed itself optimistically about the effectiveness of its antibody drug AZD7442. In the final phase of the clinical studies, the agent, which must be injected intramuscularly, achieved a “statistically significant reduction” in severe or fatal courses in Covid patients with mild to moderate symptoms. Astrazeneca announced that it will soon present the data to health authorities.

Remdesivir is the only officially approved corona drug in the EU. However, its effect fell short of expectations. US manufacturer Gilead achieved EU approval in July 2020 – but only for corona patients with pneumonia who receive additional oxygen but do not yet need invasive ventilation. In September, the Federal Joint Committee for the Health Care System in Germany saw only minor benefits of remdesivir in moderate patients and none at all in severely ill patients.

Dexamethasone is also used against Covid-19, which has an anti-inflammatory effect and dampens the immune system – and thus also overreactions to Sars-CoV-2. So far it has been administered against eczema, arthritis or brain edema.

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