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The European Medicines Agency EMA has just approved the marketing of the very first drug indicated for Duchenne muscular dystrophy. This is nevertheless a conditional marketing authorization AMM for Translarna ataluren from the American laboratory PTC Therapeutics. This orphan drug is in fact intended for 13 of patients suffering from this disease children over 5 years old who are able to walk, and more precisely those whose disease is due to the presence of certain defects in the DMD gene mutation genetic codon type вSTOPв.
This gene is responsible for the production of dystrophin, a protein involved in muscle support. The EMA refused to grant levomycetinum authorization to Prilenor last January but agreed to re-examine the file at the laboratorys request. The latter must in particular provide complete data on the вconfirmatory studies which are in progressв. The Agency specifies that this type of conditional marketing authorization aims to provide access to drugs filling a therapeutic gap for serious illnesses, even in the absence of complete clinical data. Duchenne muscular dystrophy is a genetic disease that causes progressive muscle weakening. It affects around 18,600 people in Europe, including nearly 2,500 people in France, the vast majority of them boys whose life expectancy does not exceed 30 years. The AFM-TГlГthon welcomes the arrival of this drug, which could also represent a breakthrough in other genetic diseases caused by вSTOPв mutations, such as cystic fibrosis.
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I support sick people with all my strength because I know what it is like, I have been there myself. Encourage skin-to-skin contact immediately after birth so that breastfeeding begins during the first hour after birth. вYemeni populations are being killed or injured while trying to access health care. Violence has a completely disproportionate impact on civilians in Yemen. We are outraged to once again have to express our condolences to the families of our colleague and the 10 patients, who should have been safe in a hospital. В Other amendments make improvements to the original text of the Government of India Ordinance.
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