FDA issues emergency authorisation for remdesivir to treat COVID-19

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for emergency use of Gilead’s remdesivir for the treatment of hospitalised patients with COVID-19.

President Donald Trump made the announcement in the Oval Office alongside Gilead’s CEO Daniel O’Day who stated:

“We want to thank the collaborators that brought remdesivir to this point and many of our people that have been part of this, in fact, the caregivers.”

Remdesivir to treat severe COVID-19 disease

The authorisation allows remdesivir to be used for the treatment of adults and children with severe COVID-19 disease, requiring oxygen, ventilation or extracorporeal membrane oxygenation (ECMO).

Remdesivir has demonstrated potential success in the treatment of SARS and MERS, which are also caused by coronaviruses. Some health officials in the U.S., China and other countries have been using remdesivir, which has been studied as a promising therapy for the Ebola crisis, in the hope that the medication may improve the treatment results for COVID-19. Most encouragingly, recent clinical trials have shown remdesivir can shorten the COVID-19 disease recovery time.

United States Health and Human Services Secretary, Alex Azar, said in a statement on Friday:

″[The National Institutes of Health], FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19”.

According to the remdesivir COVID-19 disease fact sheet the EUA means that remdesivir has not passed the same degree of review as an FDA-approved medication. U.S. Doctors will however be permitted to use the medication on people diagnosed and hospitalised with the COVID-19 disease even if the agency has not officially authorised the medication. It’s use is sure to be considered by healthcare professionals since there are no other approved drugs for this purpose.

Remdesivir can shorten the recovery period

Recent clinical study data revealed that the intravenous medication has helped some hospitalised COVID-19 patients by shortening their recovery period by up to 31%. Gilead has published preliminary results from his own study, demonstrating progress in at least 50 percent of patients provided with a five-day regimen of remdesivir. The Phase 3 open-label clinical trial included 397 patients with COVID-19 serious complications. Patients who received the five-day treatment experiences similar improvement as the patients who received the ten-day course.

In compliance with the EUA, the FDA guidelines provide for remdesivir to be used either a 5-day regimen or preferably 10-day regimen for intubated patients.

Prior to this authorisation for remdesivir, the FDA approved the emergency use of chloroquine and hydroxychloroquine malaria drugs to treat COVID-19. However, after it became aware of reports of “serious heart rhythm problems” in patients. Following this, the FDA released an alert against using the medications outside a hospital or formal clinical trial facility.

Gilead to manufacture 1 million rounds

Gilead Sciences announced that it intends to manufacture more than 140,000 rounds of its 10-day therapy program by the end of May, and anticipates it will be able to perform 1 million rounds by the end of 2020. The American biotech has invested sizable capital to establish a supply chain capable of large-scale manufacture of remdesivir.

Next year the pharmaceutical company would be able to manufacture “several million” rounds of the antiviral medication. Gilead also revealed it will be donating 1.5 million vials of remdesivir. The leading biotech has worked to shorten remdesivir’s manufacturing time through process optimisation, and has succeeded in reducing the typical timeline of 9 to 12 months to only 6 to 8 eight months. Gilead continues the optimisation of its chemical synthesis processes to further boost remdesivir deliveries and volumes.

Gilead market review

Stock in Gilead (NASDAQ: GILD) was up almost 2% in extended trading. It has a market value of about $101 billion and has gained 21% since the beginning of 2020. First-quarter sales of Gilead’s HIV drugs rose to $4.1 billion from $3.6 billion a year earlier. The U.S biotech said profit was largely flat compared to the previous year as a 5% increase in sales was offset by higher costs, including spending related to the development of remdesivir.

Gilead posted adjusted earnings of $1.68 a share on revenue of $5.55 billion in the quarter. Wall Street analysts, on average, forecast a profit of $1.57 on revenue of $5.45 billion, according to Refinitiv IBES.

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