Friday, January 15, 2021
ADVT 
International

FDA approves first COVID-19 drug: antiviral remdesivir

Darpan News Desk The Canadian Press, 22 Oct, 2020
  • FDA approves first COVID-19 drug: antiviral remdesivir

U.S. regulators on Thursday approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given through an IV for patients needing hospitalization.

The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.

It had been authorized for use on an emergency basis since spring, and now becomes the first drug to win full Food and Drug Administration approval for treating COVID-19. President Donald Trump received it when he was sickened earlier this month.

Veklury is approved for people at least 12 years old and weighing at least 88 pounds (40 kilograms) who need hospitalization for their coronavirus infection. For patients younger than 12, the FDA will still allow the drug’s use in certain cases under its previous emergency authorization.

The drug works by inhibiting a substance the virus uses to make copies of itself. Certain tests are required before starting patients on it. And the label warns against using it with the malaria drug hydroxychloroquine, because that can curb its effectiveness.

“We now have enough knowledge and a growing set of tools to help fight COVID-19,” Gilead's chief medical officer, Dr. Merdad Parsey, said in a statement.

The drug is either approved or has temporary authorization in about 50 countries, he noted.

Its price has been controversial, given that no studies have found it improves survival. Last week, a large study led by the World Health Organization found the drug did not help hospitalized COVID-19 patients, but that study did not include a placebo group and was less rigorous than previous ones that found a benefit.

Gilead charges $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries, and $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors.

Only one treatment — steroids such as dexamethasone — has been shown so far to cut the risk of dying of COVID-19. The FDA also has given emergency authorization to using the blood of survivors and two companies are currently seeking similar authorization for experimental antibody drugs.

MORE International ARTICLES

Timothy Ray Brown, 1st person cured of HIV, dies of cancer

Timothy Ray Brown, 1st person cured of HIV, dies of cancer

Brown’s first transplant in 2007 was only partly successful: His HIV seemed to be gone but his leukemia was not.

Timothy Ray Brown, 1st person cured of HIV, dies of cancer

Trump-Biden 'dumpster fire' casts doubt on debates

Trump-Biden 'dumpster fire' casts doubt on debates

President Donald Trump spent most of the night needling, badgering and talking over both Democratic challenger Joe Biden and moderator Chris Wallace, fuelling a cacophony of interruptions and insults that offered little help to American voters.

Trump-Biden 'dumpster fire' casts doubt on debates

WATCH: Horror in Hathras : Victim Forcefully Cremated by UP Police Despite Protests #JusticeforManisha

WATCH: Horror in Hathras : Victim Forcefully Cremated by UP Police Despite Protests #JusticeforManisha

WATCH: The 19 year old woman 'Manisha Valmiki' passed away after fighting for her life in a New Delhi Hospital. The family has accused police officials of cremating her body without their permission.

WATCH: Horror in Hathras : Victim Forcefully Cremated by UP Police Despite Protests #JusticeforManisha

James Patterson awards $500 grants to thousands of teachers

James Patterson awards $500 grants to thousands of teachers

The grant program is administered by Patterson and by Scholastic Book Clubs, which will provide teachers 500 club points to go with the $500 from Patterson.

James Patterson awards $500 grants to thousands of teachers

NYC elementary schools reopen in big back-to-school test

NYC elementary schools reopen in big back-to-school test

With children wearing masks and undergoing temperature checks at schoolhouse doors, students and parents who opted for brick-and-mortar school greeted the twice-delayed date with enthusiasm, relief and some trepidation.

NYC elementary schools reopen in big back-to-school test

Attenborough gives shark tooth to 7-year-old Prince George

Attenborough gives shark tooth to 7-year-old Prince George

The film, “David Attenborough: A Life on Our Planet,” is a personal reflection on his career as a naturalist and the changes he has seen in the natural world during his lifetime.

Attenborough gives shark tooth to 7-year-old Prince George