Gilead’s Investigational Antiviral Drug Remdesivir Obtained FDA Emergency Use Authorization for COVID-19 treatment

  • May 04, 2020 AEST
  • Team Kalkine
Gilead’s Investigational Antiviral Drug Remdesivir Obtained FDA Emergency Use Authorization for COVID-19 treatment

The world is grappling to combat COVID-19, a tiny virus that has traumatised everyone existing on the earth. It has left millions of people jobless, sending billions into isolation and compelling nearly everyone on the planet to cope with the feeling that they or those they love are unexpectedly physically vulnerable. Hundreds of thousands have been affected, thousands have deceased, while the virus continues to spread, and as per the latest report, vaccine for this virus could take more than a year.

While the healthcare industry is struggling for developing the treatment/vaccine for coronavirus infection, at the same time, all the industries are trying to acclimate to this new world order.  The health care associates are not only treating a flood of critically infected patients during this pandemic, but they are also endangering their own health, observing higher rates of death as well as experiencing breakdowns of protocol and support.

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There are many healthcare authorities along with pharma and biotech players conducting and supporting research for medical developments to treat SARS CoV-2 induced disease. At this time, urgent public health measures are required to control the spread of the coronavirus. Researchers across the globe are in the race against the time for developing an effective treatment option for patients suffering from coronavirus; meanwhile, a US-based company Gilead Sciences offers a flicker of hope by receiving approval from US FDA for its investigational drug remdesivir.

 

In the backdrop, let us delve deep and discuss Gilead’s success-

A biopharmaceutical Company Gilead Sciences, Inc. (Nasdaq:GILD) is headquartered in California, United States and is into the development and commercialisation of innovative treatments for the diseases with an unmet medical need. The Company has its businesses in over 35 nations across the globe.

Gilead’s Remdesivir Granted FDA’s Emergency Use Authorization

On 1 May 2020, Gilead Sciences revealed that its Investigational Antiviral Drug Remdesivir has received the US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. This authorization would enable broader use of remdesivir to treat hospitalised patients with severe symptoms of infection induced by COVID-19, facilitating access to the antiviral drug remdesivir at additional hospitals across the country.

The allotment for the limited available supply of remdesivir would be made on the basis of guiding standards that intents to increase the access for applicable COVID-19 patients who are in urgent requirement of treatment, with guidance from and in partnership with the government.

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The investigational antiviral drug of Gilead is authorised for treating the patients who are in hospital with severe COVID-19. Gilead disclosed that the optimum treatment duration is still unknown for remdesivir, and it is being studied in the current clinical studies. Under the emergency use authorization, both 5-day as well as 10-day treatment durations are recommended, based on the seriousness of the infection.

Moreover, this authorization by FDA is provisional, and presently there is not any formal new drug application (NDA) submission, review and approval procedure are in place for remdesivir.

By this authorization, the drug would be granted for distribution and emergency application only for the treatment of coronavirus infection. Moreover, remdesivir is still an investigational product and has not gained an approval from FDA.

The government of the United States will coordinate the donation, as well as the distribution of remdesivir to hospitals in cities where there is a large number of patients of COVID-19.

On the backdrop of seriousness of the disease among patients apposite for treatment by remdesivir and the restricted availability of the supply of drug, hospitals with intensive care units (ICU) and other hospitals, which the government considers are in maximum need of it,will obtain priority for the supply of remdesivir.

 

 

DO READ: How Healthcare and Research Companies are Coming up with Ground-Breaking Technologies to Deal With COVID-19

Production and Supply of the Investigational Antiviral Remdesivir

Gilead has assertively applied a multipronged method for increasing the production and quickly build the supply of its antiviral drug remdesivir. The Company has made significant investment, in jeopardy, to meet the supply demands for clinical studies along with the emergency treatment programs.

By the process enhancements, the Company has significantly curtailed the production time from raw materials through to completed produce. Additionally, GILD has also augmented the internal production with substantial supplementary capacity from various partners in Europe, North America, and Asia.

Now, the Company expects being capable enough to cover up considerably more patients based upon the outcomes of the SIMPLE clinical trial, which showed comparable efficacy with the both five and 10-day dosing regimen in patients with critical infection. 

It is noteworthy to mention that, looking forward, GILD is developing a geographically distinct association of prominent pharma as well as chemical producing players, which will help the Company to reach and surpass goals of manufacturing of remdesivir, and go beyond what it could accomplish individually.

ALSO READ: Medical Developments in Race Against COVID-19

Some Crucial Information About Remdesivir

Gilead disclosed a few vital information that are related to its antiviral drug Remdesivir or GS-5734™, authorised for use under a EUA only for treating the patients with suspected or laboratory-confirmed COVID-19, including the seriously ill patients. The disease severity is specified as patients with an oxygen saturation is equal to or less than 94% on room air or needing supplementary oxygen or extracorporeal membrane oxygenation (ECMO), or mechanical ventilation. This drug is FDA authorised for adult or pediatric patients who are hospitalised and for patients to use an intravenous drug is clinically suitable, as it must be given intravenously.

The antiviral drug Remdesivir is under investigation and has not been approved by the FDA for any use, and also it is not yet known if the drug is safe and effective for the treatment of coronavirus infection.

Moreover, Gilead also discussed that the healthcare practitioners and/or their designee are responsible for mandatory reporting of all medication errors and any serious adverse drug reaction or fatality befalling during remdesivir treatment, in FDA MedWatch. Any adverse drug reactions (ADRs) after the use of remdesivir should be informed within seven days after the onset of the occurrence of ADR, and the MedWatch adverse event reports must be submitted to the FDA.

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On 1 May 2020, Gilead last traded at USD 79.95, down by 4.82 percent from the previous closing price.

 


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