COVID-19 | Hopes ride high on Gilead’s remdesivir as breakthrough Coronavirus drug

COVID-19 | Hopes ride high on Gilead’s remdesivir as breakthrough Coronavirus drug thumbnail
Remdesivir is the new word for hope in a world fighting an increasingly difficult battle against coronavirus that has afflicted all continents but one, spread to 177 countries, sickened more than 382,393 people and left 16, 568 dead.An experimental drug of American pharma major Gilead Sciences Inc, remdesivir is being seen as a potential treatment…

Remdesivir is the new word for hope in a world fighting an increasingly difficult battle against coronavirus that has afflicted all continents but one, spread to 177 countries, sickened more than 382,393 people and left 16, 568 dead.An experimental drug of American pharma major Gilead Sciences Inc, remdesivir is being seen as a potential treatment for coronavirus, as trials enter a crucial phase.On March 23, remdesivir, an investigational antiviral developed by Gilead for use against Ebola, received the “orphan drug” designation from the Food and Drug Administration (FDA), the US drug regulator.The status is granted to a drug that shows promise in the treatment, prevention or diagnosis of a rare disease. These drugs are called orphan because they are commercially underdeveloped and production needs government support.Track this blog for latest updates on coronavirus outbreakThis status entitles Gilead to a range of incentives, including a seven-year market exclusivity period and tax breaks to develop the drug.“Gilead is working closely with global health authorities to respond to the novel coronavirus (COVID-19) outbreak through the appropriate experimental use of the investigational compound remdesivir,” the company said in a statement.Gilead has already initiated Phase III clinical trials that involve randomised testing in hundreds of patients for remdesivir’s effectiveness. According to estimates, 70-90 percent of the drugs that go into Phase III successfully complete this make-or-break stage of testing.The results and data readouts of remdesivir’s Phase III trials are expected in April. If they go well, then the company can seek FDA’s nod to market the drug. The virus connectionRemdesivir has demonstrated in vitro (test tube) and in vivo (in body) activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses that are structurally similar to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), as the coronavirus has been named.The company said the limited preclinical data on MERS and SARS indicated that remdesivir may have potential potency against SARS-CoV-2.On March 22, the Foster City-headquartered company said it was temporarily putting new emergency access to remdesivir on hold due to a sharp increase in “compassionate-use” requests.A medicinal product given on a compassionate basis is first and foremost a treatment. It is a medicinal product not yet fully evaluated, prescribed to treat people with no other therapeutic options.Under the “compassionate-use programme” widely practised in many parts of the world, drugs are made available to a group of patients or sometimes individual patients who cannot be treated by an authorised medicine.The sharp spike in “compassionate use” requests raised hopes about the drug’s effectiveness as a potential treatment for Covid-19, the disease caused by the novel coronavirus.The requests flooded an emergency treatment system set up for limited access to investigational medicines and never intended for use in response to a pandemic.“To streamline the emergency access process, Gilead is currently in the process of transitioning from individual compassionate use requests to expanded access programs. This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients,” the company said.Once commercially available, the medicine’s price, particularly for countries such as India, will remain a key question.Gilead may offer the remdesivir to local partners in India under mutually agreed terms to keep the drug’s price affordable.Remdesivir evolved from research in the mid-2010s to test compounds against new viruses. While early results from tests done on animals showed promise as a potential treatment against Ebola, but a large Phase III trial in the Democratic Republic of the Congo showed it wasn’t very effective in preventing deaths from the virus.These experiments have now assumed prominence, as MERS and SARS viruses mirror strong genetic similarities to SARS-CoV-2.Researchers expect the FDA to fast track the approval, subject to Phase III results as it did in 1987 for azidothymidine— AZT—the first HIV/AIDS medicine.FDA accelerated its approval on the condition that the drug maker—Burroughs Wellcome—would continue to study patients taking the drug, and report the results. A similar approach to remdesivir cannot be ruled out, but it all hinges on the outcome of Phase III trials.Time to show-off your poker skills and win Rs.25 lakhs with no investment. Register Now!
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