Gilead’s remdesivir, first coronavirus treatment approved by FDA, ‘historic’: Azar
HHS Secretary Alex Azar gives update on coronavirus treatments, testing, and vaccines.
Gilead Science's antiviral drug remdesivir is now officially approved by the Food and Drug Administration as the first treatment for COVID-19 in the United States.
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The approval came following new results published in the New England Journal of Medicine Thursday from Gilead's Phase 3 ACTT-1 trial, which demonstrated faster recovery times than previously reported for the treatment of adults hospitalized with mild-moderate or severe coronavirus cases. Remdesivir was also found to reduce disease progression among severely ill patients who require oxygen.
FOX Business takes a look at five facts on the drug, including its economics.
FDA APPROVES GILEAD'S REMDESIVIR AS FIRST COVID-19 TREATMENT
1. How remdesivir is administered
Remdesivir is administered intravenously for the treatment of patients ages 12 and older with COVID-19 requiring hospitalization. Once injected, remdesivir is designed to be converted by the body into a chemical that disrupts the replication process of SARS-CoV-2, the virus which causes COVID-19.
According to the FDA, remdesivir should "only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care."
Doses should only be prescribed to patients weighing greater than or equal to about 88 pounds.
For patients not requiring ventilation and/or extracorporeal membrane oxygenation (ECMO), treatment should last five days but may be extended up to 10 days if clinical improvement is not observed. Patients requiring ventilation or ECMO should be given treatment for 10 days.
WHO-BACKED STUDY FINDS NO REMDESIVIR BENEFIT FOR HOSPITALIZED COVID-19 PATIENTS
The antiviral drug, sold under the brand name Veklury, is now widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply. In addition, Gilead noted that remdesivir has also been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide.
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The Department of Health and Human Services noted that the cost of remdesivir will not change in the transition from U.S. government oversight of allocation to direct commercial sales, with hospitals set to pay no more than Gilead's wholesale acquisition price of approximately $3,200 per treatment course.
Generally, patients do not pay directly for hospital-administered drugs. Instead, the cost is typically covered by Medicare and most private insurers and incorporated into the overall treatment costs based on the patient's diagnosis.
4. Side Effects
Possible side effects of remdesivir include increased liver enzyme levels and allergic reactions which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling of the lips, eyes or under the skin, rash, nausea, sweating or shivering.
5. Can Treat SARS, Ebola & Others
According to Gilead, remdesivir has shown broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV. However, it has not been approved as an official treatment for any of the viral diseases.
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