Current on COVID-19: Remdesivir Approval, At-Home Test, Point of Care Materials, and NIH Partnership

Here is some of the latest news regarding the COVID-19 situation from the past week.

Gilead’s Remdesivir Gets Emergency FDA Approval for COVID-19

Days after clinical data showed Gilead’s remdesivir was effective in shortening the recovery time of some patients hospitalized with COVID-19, the FDA has granted the drug emergency use authorization (EUA).

An EUA designation means that even though the drug has not gone through the same levels of rigorous testing as an FDA-approved treatment, doctors are now allowed to use the drug to treat hospitalized COVID-19 patients. The authorization is temporary and does not take the place of the formal new drug application submission, review, and approval process.

FDA chief scientist Denise Hinton wrote the FDA’s emergency approval letter for remdesivir, saying, “Based on the totality of scientific evidence available to FDA, it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of remdesivir when used to treat COVID-19 outweigh the known and potential risks of such products.”

The optimal duration of treatment is still being studied in ongoing clinical trials. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease. The 10-day dosing duration is suggested for patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), and the 5-day dosing duration is suggested for patients not requiring invasive mechanical ventilation and/or ECMO.

Gilead has donated 1.5 million individual doses of remdesivir, which is the entirety of its existing supply of finished and unfinished product. This equates to more than 140,000 treatment courses that will be provided at no cost to treat patients following potential emergency authorizations and regulatory approvals, including this EUA.

“This EUA opens the way for us to provide emergency use of remdesivir to more patients with severe symptoms of COVID-19,” Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, said in a statement. “We will continue to work with partners across the globe to increase our supply of remdesivir while advancing our ongoing clinical trials to supplement our understanding of the drug’s profile. We are working to meet the needs of patients, their families, and healthcare workers around the world with the greatest sense of urgency and responsibility.”

FDA Approves First At-Home COVID-19 Test

LabCorp received FDA Emergency Approval for a coronavirus testing kit that requires users to swab their nose and send in the sample for lab testing. The company is prioritizing healthcare workers and first responders as the first to receive the kits. This not only means that more people will be tested, but that doctors can limit their exposure since they won’t have to administer tests and can free up much needed protective equipment. The test costs $119.

The test will be less accurate than those conducted by physicians; doctors are able to slide a swab all the way through the nose and to the back of the throat, providing a better sample. The at-home test will be less invasive. While not as accurate, the emergency approval was granted in order to address the severe shortage of tests in the U.S. About 147,000 COVID-19 tests are reported in the United States each day, which experts say is still far lower than the number of tests needed to bring the outbreak under control.

Outcome Health Provides POC COVID-19 Info

While many of us are finding ways to stay busy inside, people with chronic conditions are forced to risk exposure by visiting doctors’ offices. In this fearful environment, these patients require the most reassurance and information about guarding their health. Outcome Health is tailoring content that is particularly valuable at specialty clinics and hospital systems serving patients with chronic illnesses. These visuals reach patients with diabetes, multiple sclerosis, cancer, or those who are on dialysis—vulnerable populations that represent some of the largest at-risk patient populations for the virus. Some content even serves to help those facing domestic abuse in the home, or who are having a hard time parenting through social distancing conditions.

Urgent Care Facilities Produce Novel COVID-19 Research

Urgent care facilities, especially in New York, are often on the front lines of viral outbreaks, with a huge number of COVID-19 positive patients seeking treatment from them first. Many of these patients complain of chest pains, so the Journal of Urgent Care Medicine (JUCM) was able to publish work based on 636 chest X-rays from a large urgent care center in New York City. The majority of COVID-19 positive patients (89%) presented normal or only mildly abnormal CXRs, despite showing respiratory symptoms. The studies are important as healthcare workers work to determine accurate clinical features. It also shows the importance of urgent care facilities and their ability to gather crucial information and impact community health.

NIH Announces Partnership for Treatment and Vaccine Development

The National Institute of Health revealed a public-private partnership between federal researchers and 21 pharma companies, with more joining, to develop coronavirus treatments and vaccines. Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, will standardize research between the two sectors to speed results. Standardization will include providing researchers access to high-level laboratory facilities and ensuring different companies and researchers are judging potential medicines by the same criteria. Abbott, Bristol Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, Sanofi, Pfizer, AstraZeneca, and Eli Lilly and Company are among the big pharma companies active in the collaboration


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