The Food and Drug Administration on Tuesday approved Novo Nordisk‘s Ozempic for patients with chronic kidney disease and diabetes, expanding the use of the wildly popular injection in the U.S.
The drug is already widely used and covered to treat Type 2 diabetes. The FDA’s decision means Ozempic can now be used to reduce the risk of kidney disease worsening, kidney failure and death from cardiovascular disease in patients with both chronic kidney disease and diabetes.
The decision could transform how doctors treat patients with the condition, which involves a gradual loss of kidney function and is one of the leading causes of death in the U.S. Around 37 million American adults are living with chronic kidney disease, according to Novo Nordisk.
Diabetes is a key risk factor for kidney disease. Roughly 40% of Type 2 diabetes patients have the condition, which can cause additional sickness such as increased risk of cardiovascular problems and death, Novo Nordisk said.
“All chronic kidney disease is progressive. It’s a year-on-year, relentless decline in renal function,” Stephen Gough, Novo Nordisk’s global chief medical officer, said in an interview, referring to the kidney’s ability to filter waste from the blood.
He noted that when the condition progresses to the point of kidney failure — also known as end-stage kidney disease — patients require long-term dialysis treatments to remove waste from the blood, or a kidney transplant. Both are burdensome and death among patients with end-stage kidney disease is “very high,” particularly from cardiovascular disease, according to Gough.
The approval also demonstrates that a blockbuster class of diabetes and weight loss drugs called GLP-1s have significant health benefits beyond regulating blood sugar and suppressing appetite.
Ozempic reduced the risk of severe kidney outcomes — including kidney failure, reduction in kidney function, or death from kidney or heart causes — by 24% in diabetic patients with chronic kidney disease compared to a placebo, according to results of a late-stage trial that the approval was based on.
In patients who took Ozempic, kidney function declined more slowly, the risk of major cardiovascular events such as heart attack dropped 18% and the risk of death from any cause fell 20% compared with the placebo. Ozempic also cut the risk of cardiovascular-related deaths by 29%.
“We know that, unfortunately, cardiovascular disease and chronic kidney disease just go hand in hand,” Gough said.
He added that the major treatments patients typically receive when they have the earliest signs of chronic kidney disease aim to reduce cardiovascular risk factors by paying attention to blood pressure.
The rate of serious adverse side effects was 49.6% in patients who took Ozempic, lower than the 53.8% seen in the group that received a placebo. There was a slightly higher rate of discontinuations among Ozempic patients due to gastrointestinal side effects commonly seen with GLP-1s, such as nausea and vomiting.
EU regulators approved Ozempic for the same use in December.
The Danish company ended the phase three trial in October, a year earlier than expected, in response to positive results. At the time, Novo Nordisk’s announcement caused shares of kidney dialysis companies to plummet about 20% in a single day.
The trial, called FLOW, first started in 2019 and followed roughly 3,500 patients with diabetes and moderate to severe chronic kidney disease.
“From my point of view as a doctor, you don’t get [diabetes, obesity, chronic kidney disease and cardiovascular disease] in isolation,” Gough said. “These illnesses, unfortunately, co-segregate. They cluster within the same individuals. So if you have a medicine that can target each of these co-morbidities in one injection, then you’re addressing what really matters to the patient”
The approval comes after the Biden administration selected three of Novo Nordisk’s drugs with the active ingredient semaglutide for the second cycle of Medicare drug price negotiations. That includes Ozempic, its weight loss counterpart Wegovy and another diabetes treatment called Rybelsus.
The FDA’s decision also comes as Novo Nordisk faces increased competition from Eli Lilly and tries to win expanded insurance coverage for its separate weight loss injection Wegovy.
Last year, Wegovy won approval in the U.S. for slashing risk of major cardiovascular events such as heart attacks and strokes. Novo Nordisk is also studying Wegovy as a potential treatment for fatty liver disease.
ADVERTISEMENT:
Halo, sobat pengemar slot! pernahkah denger istilah “slot gaco”? Kalau tidak, siap-siap jatuh cinta sama program ini. slot demo adalah mesin slot yang sering kasih kemenangan. Yup, slot-slot ini bisa disebut sebagai jagoannya tuk bawa pulang cuan. but, cemana sih
tekniknya nemuin slot gaco yang benar? Santai Bro and Sis, kita bahas tenang saja di sini
Permainan tergacor saat ini satu-satunya berada Indonesia hanya di pasti menyediakan imbal hasil terbesar
Daftarkanlah hanya di :
Informasi mengenai KING SLOT, Segera Daftar Bersama king selot terbaik dan terpercaya no satu di Indonesia. Boleh mendaftar melalui sini king slot serta memberikan hasil kembali yang paling tinggi saat sekarang ini hanyalah KING SLOT atau Raja slot paling gacor, gilak dan gaco saat sekarang di Indonesia melalui program return tinggi di kingselot serta pg king slot
slot demo gacor
slot demo gacor permainan paling top dan garansi imbal balik hasil besar bersama kdwapp.com
akun demo slot gacor
akun demo slot gacor permainan paling top dan garansi imbal balik hasil besar bersama kdwapp.com
akun slot demo gacor
akun slot demo gacor permainan paling top dan garansi imbal balik hasil besar bersama kdwapp.com
akun demo slot pragmatic
akun demo slot pragmatic permainan paling top dan garansi imbal balik hasil besar bersama kdwapp.com
akun slot demo pragmatic
akun slot demo pragmatic permainan paling top dan garansi imbal balik hasil besar bersama kdwapp.com
akun slot demo
akun slot demo permainan paling top dan garansi imbal balik hasil besar bersama kdwapp.com
akun demo slot
akun demo slot permainan paling top dan garansi imbal balik hasil besar bersama kdwapp.com
slot demo gacor
slot demo gacor permainan paling top dan garansi imbal balik hasil besar bersama jebswagstore.com
akun demo slot gacor
akun demo slot gacor permainan paling top dan garansi imbal balik hasil besar bersama jebswagstore.com
akun slot demo gacor
akun slot demo gacor permainan paling top dan garansi imbal balik hasil besar bersama jebswagstore.com
akun demo slot pragmatic
akun demo slot pragmatic permainan paling top dan garansi imbal balik hasil besar bersama jebswagstore.com
akun slot demo pragmatic
akun slot demo pragmatic permainan paling top dan garansi imbal balik hasil besar bersama jebswagstore.com
akun slot demo
akun slot demo permainan paling top dan garansi imbal balik hasil besar bersama jebswagstore.com
akun demo slot
akun demo slot permainan paling top dan garansi imbal balik hasil besar bersama jebswagstore.com
slot demo gacor
slot demo gacor permainan paling top dan garansi imbal balik hasil besar bersama demoslotgacor.pro
akun demo slot gacor
akun demo slot gacor permainan paling top dan garansi imbal balik hasil besar bersama demoslotgacor.pro
akun slot demo gacor
akun slot demo gacor permainan paling top dan garansi imbal balik hasil besar bersama demoslotgacor.pro
akun demo slot pragmatic
akun demo slot pragmatic permainan paling top dan garansi imbal balik hasil besar bersama demoslotgacor.pro
akun slot demo pragmatic
akun slot demo pragmatic permainan paling top dan garansi imbal balik hasil besar bersama demoslotgacor.pro
akun slot demo
akun slot demo permainan paling top dan garansi imbal balik hasil besar bersama demoslotgacor.pro
akun demo slot
akun demo slot permainan paling top dan garansi imbal balik hasil besar bersama demoslotgacor.pro
slot demo gacor
slot demo gacor permainan paling top dan garansi imbal balik hasil besar bersama situsslotterbaru.net
akun demo slot gacor
akun demo slot gacor permainan paling top dan garansi imbal balik hasil besar bersama situsslotterbaru.net
akun slot demo gacor
akun slot demo gacor permainan paling top dan garansi imbal balik hasil besar bersama situsslotterbaru.net
akun demo slot pragmatic
akun demo slot pragmatic permainan paling top dan garansi imbal balik hasil besar bersama situsslotterbaru.net
akun slot demo pragmatic
akun slot demo pragmatic permainan paling top dan garansi imbal balik hasil besar bersama situsslotterbaru.net
akun slot demo
akun slot demo permainan paling top dan garansi imbal balik hasil besar bersama situsslotterbaru.net
akun demo slot
akun demo slot permainan paling top dan garansi imbal balik hasil besar bersama situsslotterbaru.net
situs slot terbaru
situs slot terbaru permainan paling top dan garansi imbal balik hasil besar bersama situsslotterbaru.net
slot terbaru
slot terbaru permainan paling top dan garansi imbal balik hasil besar bersama situsslotterbaru.net
soda96 permainan paling top dan garansi imbal balik hasil besar bersama soda96.com
sparta88 permainan paling top dan garansi imbal balik hasil besar bersama sparta88.biz
sugesbola88 permainan paling top dan garansi imbal balik hasil besar bersama sugesbola88.org
tektok7777 permainan paling top dan garansi imbal balik hasil besar bersama tektok7777.com
tektok88 permainan paling top dan garansi imbal balik hasil besar bersama tektok88.biz
toinktoto88 permainan paling top dan garansi imbal balik hasil besar bersama toinktoto88.com
tokek888slot permainan paling top dan garansi imbal balik hasil besar bersama tokek888slot.com
topslot888 permainan paling top dan garansi imbal balik hasil besar bersama topslot888.biz
tuanslot888 permainan paling top dan garansi imbal balik hasil besar bersama tuanslot888.club
uang88 permainan paling top dan garansi imbal balik hasil besar bersama uang88.biz
uang8888 permainan paling top dan garansi imbal balik hasil besar bersama uang8888.com
userslot88 permainan paling top dan garansi imbal balik hasil besar bersama userslot88.info
uus88 permainan paling top dan garansi imbal balik hasil besar bersama uus88.biz
waslot88 permainan paling top dan garansi imbal balik hasil besar bersama waslot88.asia
wayantogel88 permainan paling top dan garansi imbal balik hasil besar bersama wayantogel88.com
zona666 permainan paling top dan garansi imbal balik hasil besar bersama zona666.biz
zona88 permainan paling top dan garansi imbal balik hasil besar bersama zona88.biz
slot96 permainan paling top dan garansi imbal balik hasil besar bersama slot96.biz
arjuna69 permainan paling top dan garansi imbal balik hasil besar bersama arjuna69.com
hqtoto88 permainan paling top dan garansi imbal balik hasil besar bersama hqtoto88.com
bangshun88 permainan paling top dan garansi imbal balik hasil besar bersama bangshun88.com
btc999 permainan paling top dan garansi imbal balik hasil besar bersama btc999.org
supraslot888 permainan paling top dan garansi imbal balik hasil besar bersama supraslot888.net
sortoto88 permainan paling top dan garansi imbal balik hasil besar bersama sortoto88.net
logamtoto88 permainan paling top dan garansi imbal balik hasil besar bersama logamtoto88.net
goslot777 permainan paling top dan garansi imbal balik hasil besar bersama goslot777.info
gebyar88 permainan paling top dan garansi imbal balik hasil besar bersama gebyar88.biz
botak88 permainan paling top dan garansi imbal balik hasil besar bersama botak88.biz
ibis88 permainan paling top dan garansi imbal balik hasil besar bersama ibis88.asia
autobot777slot permainan paling top dan garansi imbal balik hasil besar bersama autobot777slot.com
jwmarriott88 permainan paling top dan garansi imbal balik hasil besar bersama jwmarriott88.com
reddoorz88 permainan paling top dan garansi imbal balik hasil besar bersama reddoorz88.com
hotelharris88 permainan paling top dan garansi imbal balik hasil besar bersama hotelharris88.com
novotel88 permainan paling top dan garansi imbal balik hasil besar bersama novotel88.com
orientalplay88 permainan paling top dan garansi imbal balik hasil besar bersama orientalplay88.com
oyo88 permainan paling top dan garansi imbal balik hasil besar bersama oyo88.live
agoda88 permainan paling top dan garansi imbal balik hasil besar bersama agoda88.asia
tiket88 permainan paling top dan garansi imbal balik hasil besar bersama tiket88.asia
santika88 permainan paling top dan garansi imbal balik hasil besar bersama santika88.org
grandaston88 permainan paling top dan garansi imbal balik hasil besar bersama grandaston88.com
booking88 permainan paling top dan garansi imbal balik hasil besar bersama booking88.org
grandmercure88 permainan paling top dan garansi imbal balik hasil besar bersama grandmercure88.com
tripadvisor88 permainan paling top dan garansi imbal balik hasil besar bersama tripadvisor88.com
hotelmulia88 permainan paling top dan garansi imbal balik hasil besar bersama hotelmulia88.com
aryaduta88 permainan paling top dan garansi imbal balik hasil besar bersama aryaduta88.com
shangrila88 permainan paling top dan garansi imbal balik hasil besar bersama shangrila88.com
holidayinn88 permainan paling top dan garansi imbal balik hasil besar bersama holidayinn88.com
antam88 permainan paling top dan garansi imbal balik hasil besar bersama antam88.info
