The U.S. Food and Drug Administration approved Gilead Sciences Inc.’s antiviral therapy remdesivir on Thursday for use in adult and pediatric patients that are 12 years of age and older and weighing at least 40 kilograms or about 88 pounds for the treatment of COVID-19 requiring hospitalization.
In a press release Gilead said that, “Veklury is now the first and only approved Covid-19 treatment in the United States.” The antiviral drug was one of the treatments President Donald Trump received during his recent COVID-19 infection.
“Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead Chairman and CEO Daniel O’Day said in a statement. “It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need.”
The approval of remdesivir, sold under the brand name Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.
“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. 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,” said FDA Commissioner Stephen M. Hahn, M.D.
The antiviral drug is now widely available in hospitals across the United States as manufacturing capacity has rapidly expanded states Gilead.
Shares of Gilead surged 7% in pre-market trading on Friday. According to 13 surveyed by Bloomberg, analysts estimate that remdesivir will have sales of $2.17 billion this year.
In June, Gilead said it will charge U.S. hospitals roughly $3,120 for most patients who need remdesivir.
The approval of the antiviral drug is based on a U.S. government-sponsored trial involving more than 1,000 hospitalized coronavirus patients which found that those who received the drug recovered about five days faster than those who got a placebo.
The overall side-effect rate was similar to the placebo in the government study. The most common side effects are nausea and elevated liver enzymes, according to the product’s label. “ Possible side effects include: increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering,” Gilead said. “Similar safety information about using Veklury to treat COVID-19 in certain hospitalized pediatric patients under the EUA is available in the fact sheets for health care providers and patients/caregivers.”
The approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020, the Gilead press release stated. “In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.“
A World Health Organization’s study previously revealed that the drug hasn’t been proven to reduce deaths from COVID-19. In a WHO trial, Remdesivir failed to reduce fatalities, according to preliminary results that were posted last week.
Gilead has criticized the WHO study in a letter by Chief Medical Officer Merdad Parsey which was posted on the company’s website stating that the findings do not negate other results.
The FDA is an agency within the U.S. Department of Health and Human Services with a mandate to protect public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of U.S. food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.