Filenews 13 November 2021 - by Marilena Panagi
Significantly enhance the "arsenal" of doctors around the world, the new pharmaceutical formulations that began in recent times to receive approvals for their use from the competent Regulatory Authorities, such as the two formulations "Ronapreve (casirivimab / imdevimab)" and "Regkirona (regdanvimab)" approved the day before yesterday by the European Medicines Agency (EMA) and based on antiviral monoclonal antibodies.
However, scientists around the world warn that the impression should not be given that medicines can end the pandemic, as their use is specific and in no way can they replace vaccination, as they do not prevent infection but strike at serious disease and death in people who are mainly in a high-risk situation.
The high cost of these formulations ($700 -$1000 per treatment) and the way they are procured is something that concerns the various governments, while from the European Union's point of view, for the time being, the common market procedure is being followed, as was the case with vaccines against the coronavirus, which also facilitates smaller states, such as Cyprus. That is why the Deputy Director of Pharmaceutical Services, Elena Panagiotopoulou, also confirmed in her statements last Wednesday, saying that "Cyprus participates in all EU procedures and immediately after the approval of the medicines, their supply will begin, as was the case with the vaccines last December".
Regarding the value of medicines that have either been approved so far or are in the process of being approved, Mrs. Panagiotopoulou made it clear that in no case "medicines do not replace vaccination. We have antiviral drugs for other diseases but we are not saying, we will be left unprotected when there are vaccines because if we get infected there are medicines." The drugs that go for approval, "are addressed to patients with specific characteristics, for people who belong to the vulnerable groups and aim to prevent death".
In the same vein, the statements of the Associate Professor in the pharmacy program of the University of Nicosia, Christos Petrou, who told "F" that, "internationally we see the scientific community being vigilant in order to explain that the coveted approval of antiviral drugs for the covid-19 disease caused by the coronavirus, will not end the pandemic since these drugs are not addressed to everyone and we do not know whether in the future they will prove to have preventive use". They are "an extremely important tool in the hands of doctors but for their proper use the necessary protocols must be prepared without creating illusions that they will come and their arrival will bring the end of the pandemic". Studies on drugs, he said, were done/are done on a much smaller sample of people than vaccines and generally the development of such anti-antivirals is a difficult process. Their prices are very high ($700/per treatment), they have specific indications and many side effects." Drugs, when they come, he stressed, "will not be a preventive tool like vaccines, but they are an additional line of defence, especially in cases of patients who are at high risk or in patients in whom vaccines cannot be effective, such as immunocompromised ones."
In no case, he stressed, "should we not consider that if we remain unvaccinated and completely unprotected, when we get sick we will take the medicine and solve the problem. Drugs, to some extent, prevent/slow down the serious outcome of the disease and protect against death, and certainly from studies we see that lives will be saved. These drugs certainly will not be of widespread use, but undoubtedly their approval will be a big step, the biggest after the vaccines are approved."
"Ronapreve" and "Regkirona"
The two formulations approved by the EMA are based on antiviral monoclonal antibodies and are administered on the basis of specific indications and only inpatient.
Analytically:
- Ronapreve is recommended for the treatment of coronavirus in adults and adolescents, from 12 years of age and weighing at least 40 kg, who do not need supplemental oxygen and who are at increased risk of worsening their state of health. It can also be used to prevent coronavirus disease in people aged 12 years and older weighing at least 40 kg. Approval was obtained from the company 'Roche Registration GmbH'.
- Regkirona is recommended for the treatment of adults with coronavirus who do not need supplemental oxygen and who are also at increased risk of getting their disease worse. The company that received the approval is "Celltrion Healthcare Hungary Kft".
As the competent European Commissioner Stella Kyriakides said in her statements at the announcement of the EMA's decision, "two such agreements have been signed and negotiations are underway for more treatments evaluated by the EMA, while Member States can invoke the contract for the purchase of 55 thousand Ronapreve treatments. At the moment, the EMA is evaluating six more drugs that can be approved soon."
The antivirals of Merck and Pfizer
Promising messages in dealing with COVID-19 have given the two antiviral formulations manufactured by companies Merck and Pfizer. However, in this case too, the manufacturing companies stress that their formulations are not aimed at the general population.
According to the information released, both drugs are administered for five days in two doses:
- Pfizer's three pills in the morning and three in the evening.
- Merck's four in the morning and four in the evening.
The Pfizer pill, "belongs to the class of protease inhibitors and blocks an enzyme that the coronavirus needs to multiply within the patient's body." According to the company, "the virus cannot gradually acquire resistance to the new drug, which is administered in combination with another, ritonavir, an older antiviral that enhances the action of protease inhibitors (but can cause gastrointestinal side effects and 'interference' with other drugs)." Pfizer reported that about 20% of patients in clinical trials, one in five, had some side effects, mostly mild. Serious side effects were reported for 1.7% of patients who took the pill (compared to 6.6% of those who took the placebo).
Merck's pill "activates a biological mechanism that aims to cause errors in the genetic code of the coronavirus." According to the company, "because it brings about random genetic mutations in the virus, it is difficult for the virus to become resistant to the drug."
Merck said that "12% of patients who took the pill had side effects" but assured that similar studies of her new drug for a longer period of time and in larger doses than those used in humans, show that her pill does not cause birth defects or cancer.
Merck has struck a deal with the U.S. to procure 1.7 million treatment lines, at a total cost of $1.2 billion, or about $700 for each row (i.e. for each "package" of pills for five days). Britain struck a deal for 250,000 rows of Pfizer pills, but at a price that was not disclosed.
