New Greek drug cuts deaths from Covid by up to 50%, according to panel that approves new drugs for the European Medicines Agency.
Kineret® (anakinra) received the green light of the Committee for Medicinal Products for Human Use (CHMP) of the EMA for the treatment of patients with pneumonia linked to Covid-19.
A study designed and coordinated by the Greek Sepsis 2 Study Team, led by Professor Evangelos Giamarellos-Bourboulis, was carried out in collaboration with 37 centers in Greece and Italy.
“For the first time in the history of medicine, there is an antiviral drug that has been authorized by the European Medicines Agency, with Greek coordination and design,” Giamarellos-Bourboulis said after receiving the green light of the EMA for the drug.
The dramatic results of the study were published in the journal Natural medicine.
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The drug had actually been on the market for many years as a treatment for rheumatoid arthritis.
“Until Anakinra was approved, we only had two drugs available for patients treated for coronavirus pneumonia. Anakinra has now been added to the global quiver, ”said Giamarellos.
“The percentages are incredible. It is the most effective among the three drugs used in the hospital, ”he noted, noting that it will help greatly in the battle against the coronavirus that the national health system is currently waging.
“At a time when many countries still face tremendous pressure as they continue to treat critically ill patients, today’s positive CHMP opinion represents an important step in the treatment of COVID-19. If it is approved by the European Commission, it will be good news for many across Europe, ”said Ravi Rao, Research & Development Manager and Chief Medical Officer at Sobi, a biopharmaceutical form focused on rare diseases.
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“Anakinra now added to the global quiver”
“I would like to congratulate Professor Giamarellos-Bourboulis and his collaborators for having carried out this impressive work under such difficult conditions. We look forward to continuing the dialogue with other regulatory bodies to ensure that anakinra is available for patients with COVID-19 pneumonia, ”said Guido Oelkers, CEO of Sobi.
Anakinra has been used effectively in adult patients with Covid-related pneumonia requiring supplemental oxygen who were at risk of progressing to severe respiratory failure.
Covid-19 infections can lead to death due to an overreaction of the inflammatory response of the infected person, often referred to as a “cytokine storm”. Anakinra is an anti-inflammatory therapy that targets the cytokines themselves.
Research indicated that treatment with Anakinra resulted in a 64% relative reduction in patients progressing to severe illness and death, as well as a 55% relative decrease in mortality, which reached a level of 80% of fewer deaths for patients with cytokine storms.
The researchers also found that treatment with Kineret on top of the current standard of care showed marked results, reducing the risk of disease progression and death by 64% compared to the standard of care alone.
The use of Kineret is associated with an increase in the number of fully recovered patients, amounting to 50.4% and a significant reduction in the risk of death by 55% on day 28 of illness, compared to placebo.