A series of recommendations were made today by the European Medicines Agency (EMA) to address the pandemic of coronavirus.
Specifically, the EMA recommends approval of the monoclonal antibody Xevudy, approval for the use of the drug Kineret in adult patients with coronavirus and the use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19.
See in detail:
COVID-19: EMA recommends licensure of Xevudy monoclonal antibody
The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended licensure of Xevudy monoclonal antibody (sotrobimab) for the treatment of COVID-19 disease. The applicant is GlaxoSmithKline Trading Services Limited which developed the medicine in collaboration with Vir Bitoechnology.
The Committee recommended the authorisation of Xevudy for the treatment of COVID-19 disease in adults and adolescents aged 12 years and older with a body weight of at least 40 kg who do not require supplemental oxygen therapy and who are at increased risk for progression of their disease state to severe.
Xevudy is the third monoclonal antibody recommended in the EU for the treatment of COVID-19 and its approval follows those of Regkirona and Ronapreve in November 2021. Monoclonal antibodies are proteins designed to bind to a specific target, in this case the spike protein of SARS-CoV-2 (the virus that causes COVID-19), which the virus uses to enter human cells.
To reach its conclusion, the CHMP evaluated data from a study involving 1,057 patients with COVID-19 disease, which showed that treatment with Xevudy significantly reduces hospitalization and deaths in patients with at least one underlying condition that puts them at increased risk for progression to severe COVID-19 disease. After treatment with Xevudy, 1% of patients (6 of 528) were hospitalized within 29 days of treatment for more than 24 hours, compared with 6% of placebo patients (30 of 529), 2 of whom died.
The majority of patients in the study were infected with the original SARS-CoV-2 virus strain. Some patients were infected with variants such as Alpha and Epsilon. Based on laboratory studies, Xevudy is also expected to be active against other variants (including Omicron).
The safety profile of Xevudy was favourable, with a reported low number of hypersensitivity (allergy) and injection-related reactions, and the CHMP concluded that, for its approved use, the benefit of the drug outweighs the risks.
The CHMP will now send its opinion to the European Commission for a rapid decision that will apply to all EU Member States.
While the evaluation of the marketing authorisation application was ongoing, the Commission issued recommendations to help EU Member States decide on the early use of this medicinal product. This means that the medicine was already available to some patients in the EU.
More information on the evaluation of the medicine as well as the approved product information is available on the EMA website on the relevant page of the medicine.
EMA issues recommendations on the use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
The EMA Committee for Medicinal Products for Human Use (CHMP) has issued recommendations on the use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19. The drug, which is not yet approved in the EU, can be used to treat adult patients with COVID-19 disease who do not need supplemental oxygen and who are at increased risk of progression to severe disease. Paxlovid should be administered as soon as possible after diagnosis of COVID-19 disease and within 5 days of the onset of symptoms. The two active substances of the medicinal product, PF-07321332 and ritonavir, available as separate tablets, should be taken together twice daily for 5 days.
The EMA has issued this recommendation to support national authorities who may decide on possible early use of the medicinal product prior to marketing authorisation, for example in emergency situations, in light of the increasing rates of infection and deaths due to COVID-19 across the EU.
The recommendation is based on interim results from the main study in non-hospitalised, unvaccinated patients who had symptomatic disease and at least one underlying disease that put them at risk of serious COVID-19 disease. These data showed that Paxlovid reduced the risk of hospitalization and death when treatment was initiated within 5 days of symptom onset. Approximately 1% of patients (6 of 607) who received Paxlovid within five days of symptom onset were hospitalized within 28 days of starting treatment compared to 6.7% of patients (41 of 612) who received placebo (placebo). None of the patients in the Paxlovid group terminated compared with 10 patients in the placebo group.
In terms of safety, the most common adverse events reported during treatment and up to 34 days after the last dose of Paxlovid were dysgeusia (taste disturbance), diarrhea, and vomiting.
Paxlovid should not be used with certain other drugs, either because its action may lead to harmful increases in their blood levels or because, on the contrary, certain drugs may reduce the activity of Paxlovid itself. The list of drugs that should not be used with Paxlovid is included in the recommended conditions of use. Paxlovid should also not be used in patients with severely impaired renal or hepatic function.
Paxlovid is not recommended during pregnancy and in people who are likely to become pregnant and who are not using contraception. Breast-feeding should be discontinued during treatment. These recommendations are because laboratory studies in animals suggest that high doses of Paxlovid may affect fetal development.
The EMA's proposed conditions of use will be published shortly on the EMA website.
The Agency's recommendations can now be used to support national recommendations on the potential use of the medicinal product prior to marketing authorisation.
Start of rolling review
In parallel with the provision of this recommendation, a more comprehensive rolling review was initiated on 13 December 2021 in view of a possible marketing authorisation application.
The EMA will evaluate more complete data on the quality, safety and efficacy of the medicinal product as soon as they become available. The rolling review will continue until sufficient data are available for the company to submit a formal marketing authorisation application.
The EMA will provide further information when a marketing authorisation application for the medicine is submitted.
How the medicine is expected to work
Paxlovid is an oral antiviral medicine that reduces the ability of the SARS-CoV-2 virus (the virus that causes COVID-19 disease) to replicate in the body. The active substance PF-07321332 inhibits the activity of an enzyme that the virus needs to multiply. Paxlovid also provides a low dose of ritonavir (a protease inhibitor), which slows down the breakdown of PF-07321332, allowing it to stay in the body longer at levels that affect the virus. Paxlovid is expected to reduce the need for hospitalization in patients with COVID-19 disease.
EMA recommends approval for the use of the drug Kineret in adult patients with COVID-19 disease
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication of the drug Kineret (anakinra) to include the treatment of COVID-19 in adult patients with pneumonia who require supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase-type plasminogen activator receptor soluble receptor) of at least 6 ng per ml.
Kineret, which is marketed by Swedish Orphan Biovitrum AB (publ), is an immunosuppressive drug (i.e. it reduces the activity of the immune system). It is currently licensed in the EU for the treatment of various inflammatory diseases. In patients with COVID-19 disease, the drug is thought to reduce the inflammation associated with the disease and thereby reduce damage to the lower airways, preventing the development of severe respiratory failure.
Data from a COVID-19 study
To reach its conclusion, CHMP evaluated data from a study involving 606 hospitalized adult patients with moderate or severe COVID-19 pneumonia who had suPAR levels of at least 6 ng per mL. These patients received, in addition to standard of care, Kineret or placebo (placebo) by subcutaneous injection. Standard of care for most patients included low or high oxygen flow and the corticosteroid drug dexamethasone, and some also received remedesivir.
The study showed greater improvements in clinical symptoms in patients treated with Kineret in addition to standard of care compared with those who received placebo in addition to standard of care. Over the 28-day study period, Kineret reduced the risk of a patient's condition worsening to more severe disease or death compared to placebo. The therapeutic benefit of Kineret compared to placebo was supported by an increase in the number of patients who fully recovered and a reduction in the number of patients whose condition deteriorated to severe respiratory failure or death.
The study also showed that the safety of Kineret in patients with COVID-19 was similar to that observed in patients treated for the other approved indications. Therefore, the CHMP concluded that the benefits of the drug outweigh the risks for patients such as those studied in the clinical trial. The effectiveness of Kineret has not been demonstrated in patients requiring non-invasive or mechanical ventilation or extracorporeal membrane oxygenation (heart-lung bypass life support system).
More about Kineret
Kineret is a drug currently licensed in the EU for the treatment of the immune disorders of rheumatoid arthritis and Still's disease, as well as autoinflammatory periodic fever syndromes, cryopyrin-associated periodic fever syndromes (CAPS) and ecogenic Mediterranean fever. The active substance of Kineret, anakinra, is an immunosuppressive drug. It works by preventing the action of interleukin 1, a chemical messenger involved in immune processes that lead to inflammation. This messenger is involved in the inflammatory processes associated with the diseases for which Kineret is used as a treatment. . By binding to the receptors (targets on cells) to which interleukin 1 would normally bind itself, anakinra blocks the activity of interleukin 1, helping to relieve the symptoms of these diseases.
More information on the evaluation of Kineret and the approved product information is available on the EMA medicines page for Kineret.
The CHMP will now send its recommendation to the European Commission, which will issue a final decision.</B-54
Views & opinions expressed are those of the author and/or Cyprus Times.
Sourcehttps://cyprustimes.com/ygeianews/y...o-ema-gia-chrisi-farmakon-kata-toy-koronoioy/
