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Remdesivir becomes first Covid-19 treatment to receive FDA approval

The US Food and Drug Administration approved remdesivir for the treatment of coronavirus infection, the drug's maker, Gilead Sciences, said Thursday.T...

Posted: Oct 22, 2020 2:39 PM
Updated: Oct 22, 2020 3:30 PM

The US Food and Drug Administration approved remdesivir for the treatment of coronavirus infection, the drug's maker, Gilead Sciences, said Thursday.

The drug, sold under the brand name Veklury, has been used under emergency use authorization. It is the first drug to be approved for treating Covid-19.

'In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization,' the company said in a statement.

'Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.'

Earlier this month, a World Health Organization-sponsored global study found remdesivir did not help patients survive or even recover faster, but a US study found the infused drug shortened recovery time for some patients by about a third.

The FDA uses data submitted by a drug's maker when it's considering approval. Gilead submitted a study published in the New England Journal of Medicine that showed the drug shortened the course of illness from an average of 15 days to about 11 days in hospitalized patients.

The FDA also considered two other studies. One showed a slight benefit of the drug and another showed the drug did not make much difference.

'Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic,' FDA Commissioner Dr. Stephen Hahn said in a statement.

'As part of the FDA's Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.'

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 137600

Reported Deaths: 1877
CountyCasesDeaths
Multnomah29040464
Washington19216179
Marion16668247
Clackamas11989141
Lane8724113
Jackson712295
Umatilla697673
Deschutes517140
Yamhill329448
Malheur319855
Linn319449
Polk256340
Klamath252446
Josephine182636
Benton181714
Douglas175944
Jefferson173425
Union114617
Wasco111723
Columbia107518
Lincoln102717
Coos98315
Hood River97621
Morrow96310
Clatsop7075
Crook65213
Baker5825
Tillamook3692
Curry3245
Lake2485
Grant2171
Harney1806
Wallowa993
Gilliam531
Sherman470
Wheeler201
Unassigned00

California Coronavirus Cases

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Cases: 3147735

Reported Deaths: 36846
CountyCasesDeaths
Los Angeles106550515184
San Bernardino2628581594
Riverside2585322777
San Diego2255582344
Orange2214932625
Santa Clara964351181
Kern89095590
Fresno847441043
Sacramento828611157
Alameda69693886
Ventura64404507
San Joaquin59395808
Contra Costa54416487
Stanislaus43938788
Tulare42759531
Monterey37285259
San Mateo33731340
San Francisco30027278
Santa Barbara26514264
Solano26494111
Imperial25562493
Merced25048324
Sonoma24761247
Kings19760160
Placer17675188
San Luis Obispo16437151
Madera13781151
Santa Cruz12687130
Marin11930163
Yolo11014138
Shasta9920129
Butte9711134
El Dorado800259
Sutter792783
Napa782847
Lassen526916
San Benito514348
Yuba504929
Tehama446846
Tuolumne344340
Nevada329674
Mendocino325635
Amador304232
Lake268132
Humboldt249425
Glenn198522
Colusa18549
Calaveras167223
Siskiyou148413
Mono11354
Inyo100729
Del Norte8732
Plumas6055
Modoc3873
Mariposa3464
Trinity3054
Sierra880
Alpine730
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