A Bay Area drugmaker became the first to earn approval from the Food and Drug Administration for a therapeutic to help treat serious cases of COVID-19, the company and agency announced Thursday.
Remdesivir, which was developed by Gilead Science in Foster City, was shown to reduce recovery time in hospitalized patients through a trio of Phase 3 trials, including one double-blind, randomized study by the National Institute of Allergy and Infectious Diseases. The FDA approved its use for any patient 12 years or older and weighing at least 88 pounds who is hospitalized with COVID-19.
However, the antiviral drug, which works to stop the replication of SARS-CoV-2 in the body, has also garnered scrutiny from the scientific and medical community as it has been deployed under an emergency use authorization with varying degrees of success. Just days before the FDA authorization, the World Health Organization declared that the drug “has little to no effect” on patients hospitalized with COVID-19, though its findings were not peer reviewed.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Dr. Stephen M. Hahn said in a statement. “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.”
Gilead credited the government response with early investments in manufacturing that allowed the drug to be already widely available in U.S. hospitals.
“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,” company chairman and chief executive Daniel O’Day said in a statement. “The speed and rigor with which Veklury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19.”
On Wall Street, the company’s shares jumped about 4% in after-hours trading following the announcement Thursday, and were up less than 1% Friday.
Remdesivir, which will be marketed under the name Veklury, was first approved in May for emergency use on hospitalized patients with the most severe cases of the disease. In August, that authorization was expanded to include any patient that was hospitalized with COVID-19.
On Thursday, simultaneous with its approval, the FDA also issued an emergency use authorization for the drug on patients under 12 years old and less than 88 pounds who are hospitalized with the virus.
In April, Dr. Anthony Fauci, the nation’s leading infectious disease expert, called remdesivir “the new standard of care” in treating COVID-19 patients.
Last month, when President Donald Trump was hospitalized with COVID-19, his doctors said he received doses of the antiviral drug, along with the corticosteroid dexamethasone, which is one of four other potential therapies to receive an emergency use authorization. Hydroxychloroquine, once touted by the President, also received an emergency use authorization, but it was revoked when the FDA determined it was “unlikely to be effective in treating COVID-19.”
The FDA analyzed three Phase 3 studies in its approval of the Gilead drug, but documents show it weighed the results from the independent NIAID study most heavily. The other two trials were sponsored by Gilead and used as supporting evidence by the FDA.
A 10-day treatment regimen led to a median recovery time that was 50% faster than for those in the control group, according to the NIAID study. Those who received an IV of remdesivir recovered in 10 days, compared to 15 days for those who did not receive the drug. Patients who were treated with remdesivir also showed a lower mortality rate, but the difference was not statistically significant compared to the control group.
The two Gilead-sponsored trials studied the safety and efficacy of a five-day or 10-day treatment regimen, which found similar outcomes for both.
Under the FDA’s guidance to health care providers, it recommends a five-day treatment regimen, starting with an initial 200mg dose and followed by daily 100mg doses. If the patient doesn’t show improvement, the treatment can be extended another five days. However, for patients who already require supplemental oxygen, doctors may start with the extended treatment.
Few patients in the studies reported side effects from the treatment, but most common was nausea in 7% or fewer of trial participants. The FDA’s list of possible side effects is far more extensive: 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.