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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 5:13 PM
Updated: Oct 22, 2020 6:30 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.'

New York Coronavirus Cases

County data is updated nightly.

Cases: 1309403

Reported Deaths: 41974
CountyCasesDeaths
Queens1634647942
Kings1605728149
Suffolk1327482661
Nassau1187352597
Bronx1092905316
Westchester875701832
New York781983480
Erie536051407
Richmond464421394
Monroe45400804
Rockland32660821
Orange29753661
Onondaga28476541
Dutchess17424330
Oneida17346369
Albany17045266
Niagara12602251
Broome11657269
Saratoga968986
Schenectady9021135
Ulster8017199
Rensselaer7262109
Putnam674875
Chautauqua584470
Chemung5739109
Oswego505974
Ontario485583
Steuben4719131
Cayuga460874
Sullivan395449
St. Lawrence385563
Herkimer383967
Wayne381156
Genesee3803101
Cattaraugus352862
Jefferson338827
Madison324376
Livingston281542
Tompkins277925
Cortland271054
Columbia264573
Allegany241375
Montgomery234277
Clinton231718
Tioga229454
Wyoming228444
Fulton224155
Warren220142
Greene214063
Orleans200371
Chenango185044
Otsego180324
Washington161227
Lewis158224
Seneca127647
Franklin12699
Delaware106727
Essex101721
Schoharie9436
Yates86320
Schuyler74510
Hamilton1611
Unassigned62117
Out of NY0168
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