FDA issues emergency-use authorization for remdesivir to treat hospitalized patients with severe Covid-19

The experimental drug remdesivir has been approved to t...

Posted: May 2, 2020 10:51 AM

The experimental drug remdesivir has been approved to treat hospitalized patients with severe Covid-19, the US Food and Drug Administration said in a letter on Friday.

Remdesivir is the first authorized therapy drug for Covid-19 in the United States, FDA Commissioner Stephen Hahn said on Friday.

"This is an important clinical advance that showed a statistically significant reduction in time to recovery for patients with Covid-19 and is the first authorized therapy for Covid-19." Hahn said.

The FDA issued an emergency-use authorization on Friday, saying the benefits of the drug outweigh its risks in patients. An emergency-use authorization is a lower regulatory bar than full FDA approval.

Denise Hinton, the FDA's chief scientist, said in the authorization letter that there is "no adequate, approved, and available alternative to the emergency use of remdesivir for the treatment of COVID-19."

The FDA limited its authorization of the drug to adults and children with suspected or laboratory-confirmed Covid-19 and severe disease, which includes low blood oxygen levels, the need for oxygen therapy or the need for a ventilator or other intensive breathing support.

Possible side effects of remdesivir include increased levels of liver enzymes -- which may be a sign of inflammation or damage to cells in the liver -- and infusion-related reactions like low blood pressure, nausea, vomiting, sweating and shivering, the FDA said.

President Donald Trump, speaking in the Oval Office on Friday, called remdesivir a "very promising situation."

"An important treatment for hospitalized corona patients and something I spoke with Dr. Hahn and Dr. (Andrew) Fauci. I spoke with Deborah (Birx) about it. It is really a very promising situation," Trump said.

The federal government is expected to control the distribution of the drug, the FDA letter says, in order to consistently use the drug with the "terms and conditions" of the authorization.

The drug must be administered intravenously. While the optimal dosing is still unknown, Gilead Sciences, the drug's marker, recommends that patients on ventilators take the drug for 10 days and non-ventilator patients only five days.

Gilead has donated the existing supply of the drug, which could cover at least 140,000 treatment courses for patients with Covid-19.

"The company has set a goal of producing at least 500,000 treatment courses by October, 1 million treatment courses by December 2020 and millions more in 2021, if required," the company said in a statement on Friday.

"We will be working very closely to get that to patients, working with FEMA, working with other parts of the government to make sure that we get that to the patients in need as quickly as possible because there are patients out there that can benefit from this medicine today that are hospitalized," said Daniel O'Day, chief executive officer of Gilead Sciences at the Oval Office on Friday. "We don't want any time to waste for that."

O'Day thanked the patients and caregivers who participated in the drug's early clinical trials.

Earlier this week, a government-funded study found that patients who took remdesivir recovered faster than patients who did not. The drug improved recovery time for coronavirus patients from 15 to 11 days. That's similar to the effect that the influenza drug Tamiflu has on flu. Tamiflu also doesn't cure patients quickly, but can reduce how long they are sick.

New York Coronavirus Cases

County data is updated nightly.

Cases: 1619924

Reported Deaths: 47264
CountyCasesDeaths
Queens2073098698
Kings2060299023
Suffolk1602923054
Nassau1459852896
Bronx1411745821
Westchester1061292081
New York1012503863
Erie644141594
Richmond561741564
Monroe52122980
Rockland38138886
Orange36334720
Onondaga32151622
Dutchess21968406
Albany20620328
Oneida19583475
Niagara15156313
Broome14521335
Saratoga11796145
Schenectady10740177
Ulster9898227
Rensselaer8902131
Putnam824486
Chautauqua7257122
Chemung6408130
Oswego595689
Ontario573188
Steuben5463137
St. Lawrence538381
Cayuga533388
Jefferson472463
Sullivan468959
Herkimer4534106
Wayne442564
Genesee4372118
Cattaraugus435176
Madison380684
Clinton350726
Livingston348455
Tompkins342742
Columbia336094
Fulton327281
Montgomery3137105
Cortland311260
Allegany286981
Warren280755
Wyoming278549
Tioga277956
Greene260970
Orleans243380
Chenango239769
Otsego230743
Washington229552
Lewis204630
Franklin200812
Seneca157453
Delaware147833
Essex132826
Schoharie118312
Yates101126
Schuyler85712
Hamilton2792
Unassigned219119
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