Gilead Awaits FDA Approval of Remdesivir
Gilead Sciences Inc pharmaceutical company is seen after they announced a Phase 3 Trial of the investigational antiviral drug Remdesivir in patients with severe COVID-19, in Oceanside, California, U.S.
Gilead Sciences, Inc. has recently announced its application for the approval of remdesivir by the U.S. Food and Drug Administration to address COVID-19 treatment.
The antiviral medicine will take Veklury, as its brand name. In a statement, Gilead chief medical officer Merdad Parsey, M.D., Ph.D., said that the recent filing is an important milestone as they continue partnering with the U.S. government, as well as global healthcare authorities to deal with COVID-19 patients' treatment needs.
Currently, remdesivir is available for emergency use for patients suffering from severe COVID-19 symptoms.
Reports said that as soon as FDA gives the go signal, however, Veklury will be getting more extensive use. To date, the antiviral drug is already approved in other countries like Europe and Japan.
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According to Gilead, its request for FDA's approval came after the results of its three-phase trial. The drug functions by blocking the virus from duplicating itself.
Tests of the drug presented that it can reduce recovery time from infection of COVID-19 by almost one-third. According to Parsey, since the onset of this pandemic, the company has been working with urgency to develop Veklury's efficiency and safety profile. Gilead now has a strong set of data that backs the assessment of the use of the drug throughout a range of populations of COVID-19 patients confined at hospitals.
Gilead is known primarily for the treatment of illnesses like hepatitis and HIV. The company stock price reportedly surged by 30 percent during the pandemic's early stages earlier this year.
However, its shares, according to reports, have dropped recently as the increasing number of pharmaceutical firms announce that they are also currently working on vaccines, as well as other therapeutic drugs to prevent the spread of COVID-19.
At present, the company has reported its stock, which is now up just a little more than seven percent this year. Center for Medicine in the Public Interest president Peter Pitts said, "Remdesivir is not a game-changer, but it is a positive."
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Remdesivir, Considered the Most Effective Drug
In end-June, it was reported that remdesivir was believed to be the most effective drug when it comes to treating sick patients earlier in the period of their illness.
This effectiveness was compared to dexamethasone, which also reduced deaths in patients who were on ventilation, as well as those who required oxygen to support their breathing.
It was around this time too, when Gilead announced it would sell remdesivir at a price ranging from $2,340 to $3,120. Relatively, the company agreed to deliver to the U.S. most of its medical products next month.
Previous reports indicate that floor price is a bit below the $2,520 to $280 range as recommended a couple of months ago by the Institute for Clinic and Economic Review after a group of British researchers discovered the cost-effective and widely available steroid dexamethasone.
Remdesivir, at that time, was predicted to be an in-demand antiviral medicine, which was presented to be a contributor to change during the period of the pandemic.
IN CASE YOU MISSED IT: Remdesivir Priced from $2,340 to $3,120 per Patient, Way Cheaper Than Estimated, Gilead CEO Says
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Aug 13, 2020 07:00 AM EDT
