Filenews 17 December 2021
A series of recommendations were made today by the European Medicines Agency (EMA) to tackle the coronavirus pandemic.
Specifically:
The EMA recommends the authorisation of the monoclonal antibody Xevudy
The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the authorisation of the monoclonal antibody Xevudy (chotrobimab) for the treatment of COVID-19. The applicant is GlaxoSmithKline Trading Services Limited which developed the drug in collaboration with Vir Bitoechnology.
The Commission recommended the authorisation of Xevudy for the treatment of COVID-19 in adults and adolescents aged 12 years and over with a body weight of at least 40 kg who do not require complementary oxygen therapy and who are at increased risk of developing their disease condition into 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 adhere to a specific target, in this case the spike protein of the SARS-CoV-2 virus (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 COVID-19 patients, 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 out of 528) were hospitalized within 29 days of treatment for more than 24 hours, compared with 6% of patients taking placebo (30 out of 529), 2 of whom ended up.
The majority of patients in the study were infected with the original strain of the SARS-CoV-2 virus. Some patients were affected 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 small number of hypersensitivity (allergy) and infusion-related reactions reported, and the CHMP concluded that, for its authorised use, the benefit of the medicine outweighs the risks.
The CHMP will now send its opinion to the European Commission for a swift decision that will apply to all EU Member States.
As the evaluation of the application for a marketing authorisation was ongoing, the Commission issued recommendations to help EU Member States decide on the early use of this medicine. This means that the medicine was already available to some patients in the EU.
More information on the evaluation of the medicinal product as well as the approved product information is available on the EMA's website on the relevant page of the medicine.
The EMA issues recommendations on the use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
The EMA's Committee for Medicinal Products for Human Use (CHMP) issued recommendations on the use of paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19. The medicine, which is not yet authorised in the EU, can be used to treat adult patients with COVID-19 who do not need additional oxygen and who are at increased risk of developing into a serious disease. Paxlovid should be given as soon as possible after the diagnosis of COVID-19 disease and within 5 days of the onset of symptoms. The two active substances of the drug, PF-07321332 and ritonavir, available as separate tablets, should be taken together twice a day for 5 days.
The EMA issued this recommendation to support national authorities that may decide on possible early use of the medicine before marketing authorisation, for example in emergency conditions, in light of the rising 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-hospitalized, unvaccinated patients who had symptomatic disease and at least one underlying disease that put them at risk of severe illness from COVID-19. These data showed that Paxlovid reduced the risk of hospitalization and death when treatment was started within 5 days of the onset of symptoms. Around 1% of patients (6 out of 607) who received Paxlovid within five days of starting symptoms were hospitalized within 28 days of starting treatment compared to 6.7% of patients (41 out of 612) who received placebo (a dummy treatment). None of the patients in the Paxlovid group ended up compared to 10 patients in the placebo group.
In terms of safety, the most common side effects 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 due to its action it can lead to harmful increases in their blood levels or because, on the contrary, some drugs can reduce the activity of Paxlovid itself. The list of medicines 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 liver function.
Paxlovid is not recommended during pregnancy and in people who may become pregnant and who do not use contraception. Breastfeeding should be discontinued during treatment. These recommendations are because laboratory studies in animals suggest that high doses of Paxlovid may affect fetal development.
The proposed terms of use of the EMA will be published shortly on the EMA's website.
The Agency's recommendations can now be used to support national recommendations on the possible use of the medicinal product prior to marketing authorisation.
Start a rolling review
In parallel with the provision of this recommendation, a more comprehensive rolling review was launched on 13 December 2021 in view of a possible application for a marketing authorisation.
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 evidence is available for the company to submit a formal application for a marketing authorisation.
The EMA will further inform when an application for marketing authorisation for the medicinal product is submitted.
How the drug is expected to act
Paxlovid is an oral antiviral drug that reduces the ability of the SARS-CoV-2 virus (the virus that causes COVID-19) to multiply 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 (protease inhibitor), which slows down the breakdown of PF-07321332, allowing it to remain longer in the body at levels that affect the virus. Paxlovid is expected to reduce the need for hospitalization in covid-19 patients.
The EMA recommends approval for the use of Kineret in adult patients with COVID-19
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended extending the indication of the drug Kineret (anakinra) to include the treatment of COVID-19 in adult patients with pneumonia who need supplemental oxygen (low- or high-flow oxygen) who are at risk of developing severe respiratory failure, as determined by the blood levels of a protein called suPAR (soluble receptor of the plasminogen activator) of the type of urokinase) of at least 6 ng per ml.
Kineret, marketed by Swedish Orphan Biovitrum AB (publ), is an immunosuppressive medicine (i.e. 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, the drug is considered to reduce inflammation associated with the disease and thus reduce damage to the lower airways, preventing the development of severe respiratory failure.
Study data on COVID-19
To reach its conclusion, the 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 care, Kineret or placebo (a dummy treatment) by injection under the skin. Standard care for most patients included low or high oxygen flow and the corticosteroid drug dexamethasone, while some also received remdesivir.
The study showed greater improvements in clinical symptoms in patients treated with Kineret in addition to standard treatment compared to those treated with placebo in addition to standard treatment. During the 28-day period of the study Kineret reduced the risk of a patient's condition worsening to a 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 decrease in the number of patients whose condition worsened to severe respiratory failure or death.
The study also showed that the safety of Kineret in COVID-19 patients was similar to that seen in patients treated for other approved indications. Therefore, the CHMP concluded that the benefits of the drug are greater than the risks for patients such as those studied in the clinical trial. The effectiveness of Kineret has not been proven in patients who need non-invasive or mechanical ventilation or extracorporeal membrane oxygenation (heart-lung bypass life support system).
More about Kineret
Kineret is a medicine currently licensed in the EU for the treatment of immune disorders of rheumatoid arthritis and Still's disease, as well as auto-inflammatory periodic fever syndromes, periodic syndromes associated with cryopyrin (CAPS) and familial Mediterranean fever. The active substance in 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 attaching to receptors (targets in cells) to which interleukin 1 would normally adhere itself, anakinra prevents 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's medicines page for Kineret.
The CHMP will now send its recommendation to the European Commission, which will adopt a final decision.
