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Not just Anakinra. Aifa says yes to new anti Covid drugs

Not just Anakinra. Aifa says yes to new anti Covid drugs

Aifa has authorized the use of the drugs Anakinra, Baricitinib and Sarilumab for the treatment of Covid-19 infection. All the details

Aifa has authorized the use of the drugs Anakinra , Baricitinib and Sarilumab for the treatment of Covid infection19. It is an important step that the Drug Agency takes because today there are still no specific anti-Covid-19 therapies, although several experimental therapies have been tried during the pandemic.

The extraordinary meeting of the CTS

The decision came during the extraordinary meeting of the AIFA Technical Scientific Commission (CTS) on 23 September 2021. These medical prescriptions will therefore be charged to the National Health System.

Medicines for hospitalized

The three drugs, despite having their own specificities, are added to Tocilizumab , in the treatment against Covid. Tocilizumab is a monoclonal antibody that neutralizes Interlukin-6 , an inflammatory molecule produced by the immune system in response to infections, and is used primarily for the treatment of rheumatoid arthritis. The drugs approved by AIFA will be used for hospitalized patients with "worsening pneumonia" and "undergoing various levels of support with oxygen therapy". The decision to authorize its use is “based on the evidence of the recently published literature”, it widens the possibilities of treatment and at the same time allows to avoid that the possible lack of Tocilizumab could have a negative impact on the therapies.

Immunomodulating drugs

Anakinra , Baricitinib and Sarilumab are immunomodulatory drugs and are usually used to improve the body's immune response against cancer. These drugs include cytokines, molecules that normally help regulate or modulate the activity of the immune system, but also microbial agents and other synthetic drugs.

The cytokine storm

The immune system, after encountering an infectious agent, responds with the production of cytokines . Under normal conditions the responses are modulated by a self-regulating mechanism. However, the system does not always work and sometimes the inflammation becomes uncontrollable. This is the case of the " cytokine storm " the immune response due to the excessive production of inflammatory proteins that accelerate it instead of fighting the infection.

The Notch4 protein

An international study published in the Immunity journal and coordinated by prof. Raffaele De Palma , of the San Martino Polyclinic Hospital, of the University of Genoa and of the National Research Council (Cnr) of Pozzuoli, and by Talal Chatila, of Harvard University, has identified the protein responsible for the immune response harmful to the body . "The cytokine storm is a phenomenon found in patients affected by severe forms of Covid-19: this process fuels the inflammation that characterizes pneumonia due to a defect in the control system that is no longer able to block the immunity response – says to Ansa the immunologist Raffaele De Palma -. The results of the work showed that in the lung tissue of people with Covid-19 there is an abnormal presence of the Notch4 protein : the more protein there is, the more serious the patient's condition. For these reasons, Notch4 represents a possible therapeutic target to counteract lung inflammation caused not only by Covid-19, but also by all viruses capable of attacking this tissue. The results open a new way to treat lung infections "

“SAVE MORE”: all the numbers of Anakinra

The "SAVE MORE" study, published in the journal Nature Medicine , in which the IRCCS Ospedale San Raffaele participated, confirms the efficacy of Anakira in the treatment of Covid-19. "The study has shown that the use of Anakinra is capable of turning off the excessive immune response caused by severe forms of COVID-19 and drastically reducing hospitalization in intensive care and deaths – says Prof. Lorenzo Dagna , Head of the Unit. of Immunology, Rheumatology, Allergology and Rare Diseases at the IRCCS San Raffaele Hospital in Today -. The early treatment with this drug of Covid patients with respiratory failure (who need oxygen but not mechanical ventilatory support) has shown, in particular, a remarkable efficacy and a reduction in disease progression and death equal to 64. % ; a 55% decrease in relative mortality, reaching 80% in patients affected by cytokine storm; improved healing in over 50% of patients, while the number of patients with severe stationary disease was reduced by 54%; finally, the average time of discharge from hospital and from intensive care (ICU) was reduced by 1 and 4 days respectively ”.

Anakira a drug for the seriously ill

Anakinra, therefore, is a drug that responds to the need to treat severe but not yet very serious forms of Covid-19 infections. "Administered in doses of 100 mg once a day for 10 days in addition to standard therapy, it has shown remarkable therapeutic progress in patients in a phase of the disease for which there was still no medical indication supported by significant data in the literature – continues the professor. Dagna -. To date we have monoclonal antibodies that work in the very early stages of the infection, and Tocilizumab that has shown results but only in very serious patients ". Anakinra is also an affordable drug available in much of the world, and costs just over $ 25 per injection. The course of therapy is 10 injections, so the total cost is approximately 250 euros.


This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/non-solo-anakinra-aifa-dice-si-a-nuovi-farmaci-anti-covid/ on Wed, 29 Sep 2021 10:00:36 +0000.