Home » EU, green light for five therapies against Covid by October 2021

EU, green light for five therapies against Covid by October 2021

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The European Commission has announced that it has identified five treatments, defined as “promising” in the fight against Covid-19. Four of these therapies are based on monoclonal antibodies and are currently undergoing “rolling review” by the European Medicines Agency (EMA). Another is based, instead, on an immunosuppressant, which already boasts the marketing authorization for non-Covid patients and which could also be authorized for the treatment of Covid patients. These are therapies that, according to an official note, have shown “high potential” and that could receive authorization from the competent authorities by October 2021, “provided that the final data demonstrate their safety, quality and ‘effectiveness”.

The five identified therapies

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The therapies in question, we still read, are specifically based on the immunosuppressant “baricitinib”, a drug that acts on the activity of the immune system, produced by the Eli Lilly company. As for monoclonal antibodies, on the other hand, they are all subjected to a continuous review phase, which is a regulatory tool designed to accelerate the evaluation of a promising drug during a public health emergency. These are Eli Lilly’s combination of ‘bamlanivimab’ and ‘etesevimab’, the combination of ‘casirivimab’ and ‘imdevimab’ developed by Regeneron Pharmaceuticals and Hoffman-La Roche. Then, again of “regdanivimab”, of Celltrion and of “sotrovimab”, produced and developed by GlaxoSmithKline and Vir Biotechnology. The European Commission, it says, will develop a portfolio of at least 10 potential treatments against Covid by October, based on the work of a group of experts on variants of the virus. “The selection process will be objective and science-based, with selection criteria agreed with Member States. As different types of products are needed for different patient populations and different stages and severity of the disease, the Panel will identify the product categories and select the most promising therapeutic candidates for each category based on scientific criteria “, reads again in the Note. The final goal will be to have at least three new therapies authorized by October and possibly another two by the end of the year. The European Medicines Agency, however, “will initiate further rolling review processes on promising therapies by the end of 2021”, based on the results of the various trial phases.

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Identify cutting-edge therapies

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The European Commissioner for Health and Food Safety, Stella Kyriakides, said: “Today we are taking the first step towards a broad portfolio of therapies for the treatment of Covid-19. While vaccination is progressing at an increasing rate, the virus will not go away and patients will need safe and effective treatments to reduce the burden of the disease ”. The common goal, he added, is to “identify more cutting-edge therapies under development and to authorize at least three new therapies by the end of the year”. Among other things, the European Commission itself, it is recalled in the press release, recently concluded a joint procurement of monoclonal antibodies (casirivimab and imdevimab) and could start others by the end of the year. On 12 and 13 July, however, the first matchmaking event for the industry will be organized, in order to bring together the various components of the sector and accelerate the production of authorized therapies in adequate quantities.

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