‘Regkirona’: Learn all about the drug against COVID that arrives in the country – National

Experts agree that medicine
Experts agree that medicine is a good therapeutic option. (photo: Disclosure)

Now, Celltrion Healthcare, a South Korean pharmaceutical laboratory, declared that private hospitals have already intensified the negotiations for the acquisition of the drug. The expectation is that the antibody will be available in Brazil by the end of September, becoming one of the main resources available in the country for the treatment of COVID-19.

According to the laboratory, around 3,500 ampoules left South Korea this Wednesday (9/1/9). In total, the deadlines for releasing the product to enter the country should take, on average, 15 days. After that, the drug can already be marketed – enough to treat nearly 1,200 patients, according to the laboratory.

what experts say

The infectious diseases physician Carlos Starling explains that antibodies are a therapeutic option mainly for the initial forms of the disease and, in some cases, even for high-risk patients.

“At this moment when we do not have therapeutic options, especially at the beginning of the disease, every new drug, every new treatment strategy is good news, for sure. As for applicability in our environment, we still have to wait to see the policy of prices and restrictions on use for both patients in the public and private sectors”, he comments.

The scholar’s concern regarding the price that Regkirona will reach the country. “In general, these drugs are very expensive. I don’t know exactly what price this drug will get, but in general they are expensive drugs and have very specific uses for some patients,” adds Starling.

the too infectious disease Una Tupinambs reinforces the need for greater accessibility to the drug. “It’s an injectable drug that’s expensive. It blocks the virus. as if it were an antibody that blocks the action of the virus. It is considered an advance, but it has to guarantee access to the Single Health System (SUS).”

Tupinambs still advocates that further studies continue so that new solutions can be found. “I see it as good news (the arrival of drugs), but we actually need a potent antiviral. He started to get the flu, he takes this medicine. We need an antiviral that, if possible, catches the coronavirus and influenza. So we hope that the studies will continue”, he concludes.

supplementary health

The laboratory responded to the State of Minas that the value of the drug has not yet been defined. “The value is being defined, but it is a cheaper value than what exists in the market today,” he said in a note. On the other hand, the company reinforced that the supplementary health system (private network) intensified the demand for the purchase of regdanvimab.

For Michel Batista, Senior Business Manager at Celltrion Healthcare in Brazil, the use of regdanvimab by the public and private health network is very important to reduce hospitalization time due to the coronavirus.
“Since the emergency release, together with Anvisa, we have been receiving several requests from private hospitals and health plans for the purchase of regdanvimab. Meeting this demand, in addition to providing the population with a safe and effective treatment specifically developed to combat COVID-19, giving hospitals the possibility to relieve ICU beds and consequently start a process of resuming hospital routines, such as elective surgeries and others procedures”, he explains.

Regarding the sale to the federal government, the laboratory informed that “there is a series of procedures that Celltrion Healthcare is already gathering all the necessary information about.”

How the medicine works

Regdanvimab is a monoclonal antibody, that is, a biological product produced in laboratories and which reproduces antibodies that help the body to fight a specific disease. Importantly, these antibodies do not prevent the disease.

Three results of clinical trials with monoclonal antibodies – of the “mabes” type (from English monoclonal antibodies – mAbs) – were highlighted during the Anvisa vote by the reporting director, Meiruze Freitas: reduction in lung damage, reduction in viremia (presence of virus in the blood) and the risk of hospitalization.

These points even led regulatory agencies such as the North American Food and Drug Administration (FDA) and the European European Medicines Agency (EMA), as well as Anvisa, to approve this type of medicine for emergency use, in specific cases.

Celltrion’s global phase III data show that the drug reduced the risk of hospitalization or COVID-19-related death by 72% for patients at high risk of progression to severe disease and 70% for all patients.

In addition, drug-treated patients reported a significantly shorter time to clinical recovery of at least 4.7 days for patients at high risk of progression to severe COVID-19 and 4.9 days compared to placebo for all the patients.

O State of Minas separated information about the drug released by Anvisa. Check out:

medication indication

Regdanvimab is indicated for the treatment of mild-to-moderate COVID-19 in adult patients who do not require supplemental oxygen, with laboratory-confirmed Sars-CoV-2 infection, and who are at high risk of progression to the disease’s most severe form .

High risk, in the drug package insert, involves patients who meet at least one of the following criteria:

  • Have a body mass index (BMI) ≥35.
  • Have chronic kidney disease.
  • Have diabetes.
  • Have an immunosuppressive disease.
  • Are currently receiving immunosuppressive treatment.
  • Are 65 years of age or older.
  • Are 55 years of age or older and have: 1. cardiovascular disease or hypertension; OR 2. chronic obstructive pulmonary disease or other chronic respiratory disease.

Contraindications

The drug is not indicated for use in patients who:
  1. are hospitalized for complications from COVID-19;
  2. need oxygen therapy due to COVID-19; and
  3. require an increase in basal oxygen flow rate due to COVID-19 in patients undergoing chronic oxygen therapy due to underlying comorbidity unrelated to COVID-19.

Pregnancy

Reproductive and developmental studies have not been conducted with regdanvimab. Antibodies are known to cross the placental barrier, so this drug has the potential to be transferred from mother to fetus.

It is unknown, however, whether this transfer provides any benefit or risk. In view of the limited knowledge about the product, its use in pregnancy should only be considered if the possible benefit for the patient is greater than the possible risks for the fetus.

breastfeeding

There are no data regarding the excretion of regdanvimab in human milk, nor on the effects on the breastfed or on milk production.

Fertility

In the repeated dose toxicity study in non-human primates, no adverse effects were observed in the male or female reproductive organs; however, there are no conclusive studies on the impacts of regdanvimab on fertility.

Instructions for use and dosage

The injectable product is for use restricted to hospitals, preferably for use in public health programs to combat coronaviruses (Sars-CoV-2).

The recommended dose is a single dose of 40 mg/kg. This medication should be administered after a positive viral test for Sars-CoV-2 and within seven days after the onset of symptoms.

Shelf life and storage care

The shelf life of regdanvimab is 12 months, and must be stored in refrigerated conditions, between 2°C and 8°C, until the moment of use. The bottle should be kept in the product box to protect it from light.

usage restrictions

Medicine with institutional and commercial destination, preferably for use in public health programs to combat coronaviruses (Sars-CoV-2), as mentioned above. USE RESTRICTED TO HOSPITALS, SALE UNDER MEDICAL PRESCRIPTION.

The drug cannot be sold in pharmacies or drugstores.

Other medications for COVID-19

This is the fourth product authorized by Anvisa to fight COVID-19 in Brazil. Before regdanvimab, the agency had already registered a drug and authorized two combinations of monoclonal antibodies in an emergency. Check out:

  • render: Registered March 12 – manufactured by Gilead Sciences.
  • Association of monoclonal antibodies casirivimab and imdevimab: authorized for emergency use on April 20 – produced by pharmaceutical companies Regeneron and Roche.
  • Association of banlanivimab and etesevimab antibodies: authorized for emergency use May 13 – produced by Eli Lilly.

(Source: Anvisa)