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Fostemsavīrs – principiāli jaunas zāles – iekļūšanas inhibitors
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25.07.2015


ASV Pārtikas produktu un medikamentu kvalitātes sanitārās uzraudzības pārvalde (FDA) Bristol-Myers Squibb izstrādātajam HIV ārstēšanas preparātam piešķīrusi principiāli jauna ārstniecības līdzekļa ("breakthrough therapy designation") statusu. Eksperimentālais HIV iekļūšanas inhibitors „Fostemsavīrs” (fostemsavir, BMS-663068) paredzēts to pacientu terapijai, kuriem vairs nepalīdz standarta ARV preparāti, ziņo. "Drug Discovery&Development". Regulatora speciālisti lēmumu par statusa piešķiršanu pieņēma pēc tam, kad  bija izpētījuši klīnisko pētījumu rezultātus, kur tika salīdzināta  „Fostemsavīra” un „Atazanavīra” efektivitāte. Klīniskajos pētījumos, kur 2b fāze ilga 48 nedēļas, piedalījās 245 pacienti. Pētījuma rezultāti liecināja, ka abiem preparātiem ir līdzīgi virusoloģiskās atbildes un imunoloģiskās atjaunošanās rādītāji. Turklāt pacienti jaunās zāles labāk panesa tāpēc, ka tām ir mazāk blakņu. Tagad „Fostemsavīrs” iziet klīnisko pētījumu III fāzi.
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Источник: Drug Discovery&Development | "BMS Gains Breakthrough Therapy Designation for New HIV Treatment" | http://www.dddmag.com/news/2015/07/bms-gains-breakthrough-therapy-designation-new-hiv-treatment |
The Food and Drug Administration (FDA) gave Bristol-Myers Squibb (BMS) a breakthrough therapy designation for its new HIV therapy called BMS-663068.
The drug is an oral “attachment inhibitor,” which is intended for adult HIV patients who have developed resistance to other therapies currently on the market, writes FierceBiotech. 
Attachment inhibitors, also known as entry or fusion inhibitors, are meant to interfere with HIV virus’s ability to bind to cell receptors, therefore slowing the pathogen’s ability to evolve into AIDs. 
BMS said in a statement its drug is different from the other inhibitors on the market because “BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’s initial interaction with immune cells entirely, and thus blocks its entry into cell.” 
The FDA made its decision after reviewing promising data from a 48-week-long randomized Phase 2b trial.
Researchers at BMS compared BMS-663068 to a protease inhibitor called Reyataz (atazanavir) using 245 patients. They reported the results in February 2015 saying they found that both drugs demonstrated similar virologic response rates and immunologic reconstitution.
Furthermore, BMS-663068 yielded a favorable safety profile. Treatments with the compound never resulted in any serious side-effects with only a very small group of patients reporting headaches or abdominal pain.
BMS welcomed the FDA’s designation saying it “recognizes the unmet need for novel therapies for this growing group of heavily treatment-experienced patients,” suffering from HIV. 
Currently, the drug is undergoing a Phase 3 clinical trial, but the new labeling will help speed up the approval process. 




 
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