Pfizer podnio zahtjev za odobrenje za hitnu upotrebu pilule za liječenje COVID-a
PAXLOVID bi se mogao propisivati za kućno liječenje visokorizičnih pacijenata pri prvim znacima infekcije, saopštila je kompanija
Kompanija Pfizer u utorak je objavila da je podnijela zahtjev američkoj Upravi za hranu i lijekove (FDA) za odobrenje za hitnu upotrebu lijeka protiv koronavirusa u obliku pilule, javlja Anadolu Agency (AA).
Zahtjev obuhvata podatke iz najnovijih ispitivanja američke farmaceutske kompanije. Pfizer je 5. novembra saopštio da pilula PAXLOVID smanjuje rizik od hospitalizacije ili smrti od posljedica koronavirusa za 89 posto.
“Ako bi odobreni PAXLOVID bio prvi oralni antivirusni lijek te vrste, posebno dizajniran za borbu protiv SARS-CoV-2, mogao bi se propisati za kućno liječenje visokorizičnim pacijentima na prvi znak infekcije”, navodi se u saopštenju kompanije.
Do sada, svi tretmani za koronavirus koji je odobrila FDA zahtijevaju intravensku injekciju pod nadzorom zdravstvenih radnika u bolnicama i klinikama.
“S više od 5 miliona smrtnih slučajeva i bezbroj života pogođenih ovom razornom bolešću na globalnom nivou, postoji hitna potreba za opcijama liječenja koje spašavaju živote”, rekao je predsjednik i izvršni direktor Albert Bourla.
Dodao je da im je cilj da pacijenti što prije dobiju ovaj lijek, kao i da se vesele saradnji s američkom FDA-om i drugim regulatornim agencijama širom svijeta.
Iz Pfizera je ranije u utorak saopšteno da su potpisali ugovor o licenciranju s međunarodnom organizacijom “Medicines Patent Pool” koju podržava Unitaid koji omogućava drugim proizvođačima lijekova da proizvode svoje antivirusne llijekove za COVID-19 u 95 zemalja s niskim i srednjim dohotkom, koje čine otprilike 53 posto svjetske populacije.
Kompanija je napomenula da je počela ulagati do milijardu dolara za podršku proizvodnji i distribuciji pilula.
Pfizer je druga kompanija u svijetu koja je razvila pilulu za liječenje virusa, nakon Merckovog lijeka za oralno primjenu, Molnupiravira.
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