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The EU approves the first transgenic drug

The Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency, has authorized the use in the EU of the first medicine produced thanks to transgenic technology. The drug, derived from transgenic goats, will be used to treat people who lack a gene necessary to eliminate blood clots.

The drug, theATryncontains alpha antithrombin, which usually occurs naturally in the body. In cases where blood clots form spontaneously, the body clears them with antithrombin alfa before they become dangerous. However, some people lack the gene responsible for creating antithrombin alfa and are therefore prone to thromboses, which can pose serious risks during surgery or childbirth.

People with antithrombin deficiency are routinely given blood plasma-derived antithrombin-alpha as prophylaxis or in critical situations, such as surgery, to prevent blood clots from forming. These people now have an alternative. In its opinion, the CHMP authorizes the use of the drug in surgery, but not yet in pregnant women.


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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco