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Novartis and Gilead products will get their temporary authorization for use in France in the next few days. Novartis will manufacture his in France
Good news for the French. Already commercialized in the United States, two revolutionary drugs, the Kymriah of Novartis and the Yescarta of Gilead, will obtain in the coming days their temporary authorization of use (ATU) in the Hexagon. This will allow them to treat the first French patients with lymphoma, the most common blood cancer, without waiting for a European marketing authorization.
These are strictly individualized treatments since it involves reprogramming the a patient's own white blood cells to destroy their cancer cells. This family of products, called CAR-Tcells, now arrives in Europe but will continue to be manufactured in the United States first.
Facilitate the tests
In a second time, the laboratories that developed them consider European production because it takes several weeks to get these cells changed and sometimes critically ill patients die before their treatment is ready. Hence the competition between the European countries to attract the manufacturing units on their soil.
To be successful, the realization of clinical trials in the country is an badet. For this reason, in the framework of the Strategic Council of Health Industries (CSIS), measures have been announced to facilitate these tests: accelerated procedure for authorization to start the test, simplification of cell import procedures. Provisions which, if they had previously existed, might have dissuaded the French leader in the field, Cellectis, from conducting its tests abroad
Agreement with Cell4Cure
This did not prevent Novartis from include French patients in its clinical trials and choose the Hexagon for its European production. The group has signed a partnership agreement with Cell4Cure, a subsidiary of the LFB to produce the Kymriah in Ulis (Essonne). Gilead, on the other hand, will manufacture in Amsterdam because it already has a packing unit there before the expedition across the Atlantic. Celgene, who comes in third, has announced that he will start clinical trials in France.
Negotiating the price and marketing will be another matter. Recall that these products are billed $ 475,000 and $ 373,000 per patient in the United States on the basis of a healing goal.
Catherine Ducruet
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