have a sufficient supply of remdesivir in its national stockpile. canada as of 11 april 2020, access in canada was available only through clinical trials. health canada approved requests to treat twelve people with remdesivir under the department's special-access program (sap). additional doses of remdesivir are not available through the sap except for pregnant women or children with confirmed covid‑19 and severe illness. on 19 june 2020, health canada received an application from gilead for the use of remdesivir for treating covid‑19. on 27 july 2020, health canada conditionally approved the application. on 22 september 2020, minister of public services and procurement anita anand announced that canada had entered into a deal to obtain up to 150,000 vials of remdesivir from gilead starting in october. as of 8 october, remdesivir was still not widely available in alberta, because alberta health services was undertaking a "formulary review" to be completed by mid-november. czech republic on 17 march 2020, the drug was provisionally approved for use for covid‑19 patients in a serious condition as a result of the outbreak in the czech republic. european union in february 2016, orphan designation (eu/3/16/1615) was granted by the european commission to gilead sciences international ltd, united kingdom, for remdesivir for the treatment of ebola virus disease. in april 2020, the european medicines agency (ema) provided recommendations on compassionate use of remdesivir for covid‑19 in the eu. in may 2020, the committee for medicinal products for human use (chmp) of the ema recommended expanding the compassionate use of remdesivir to those not on mechanical ventilation. in addition to those undergoing invasive mechanical ventilation, the compassionate use recommendations cover the treatment of hospitalized individuals requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ecmo (extracorporeal membrane oxygenation). the updated recommendations were based on preliminary results from the niaid-actt study, which suggested a beneficial effect of remdesivir in the treatment of hospitalized individuals with severe covid‑19. in addition, a treatment duration of five days was introduced alongside the longer ten-day course, based on preliminary results from another study (gs-us-540-5773) suggesting that for those not requiring mechanical ventilation or ecmo, the treatment course may be shortened from ten to five days without any loss of efficacy. individuals who receive a five-day treatment course but do not show clinical improvement will be eligible to continue receiving remdesivir for an additional five days. in july 2020, the european union granted a conditional marketing authorization for remdesivir with an indication for the treatment of coronavirus disease 2019 (covid‑19) in adults and adolescents (aged twelve years and older with body weight at least 40 kilograms ) with pneumonia requiring supplemental oxygen. in august 2022, the european union granted a full marketing authorization for remdesivir. iran remdesivir has been also produced in iran by barakat; iran is planning to increase the productions of remdesivir ampoules from 20,000 to 150,000 ampoules per month. it has also the permission of the "food and drug administration" of mohme japan in may 2020, japan's ministry of health, labour and welfare approved the drug for use in japan, in a fast-tracked process, based on the us emergency authorization. mexico in october 2020, deputy secretary of prevention and health promotion hugo lópez-gatell ramírez stated at a news conference that mexico would not necessarily follow the united states in approving the drug for use in mexico. lópez-gatell explained that the federal commission for the protection against sanitary risk (cofepris) had already twice denied the approval of remdesivir because, in that agency's view, the evidence does not suggest "sufficient efficacy". in march 2020, cofepris authorized the drug for emergency cases, advising to give continuous surveillance of the integral health of the patient. singapore in june 2020, singapore's health sciences authority conditionally approved the usage of remdesivir in singapore. united states in march 2020, united states president donald trump announced that remdesivir was available for "compassionate use" for people with covid‑19; fda commissioner stephen hahn confirmed the statement at the same press conference. it was later revealed that gilead had been providing remdesivir in response to compassionate use requests since 25 january. on 23 march 2020, gilead voluntarily suspended access for compassionate use (excepting cases of critically ill children and pregnant women), for reasons related to supply, citing the need to continue to provide the agent for testing in clinical trials. in may 2020, the us food and drug administration granted gilead emergency use authorization (eua) for remdesivir to be distributed and used by licensed health care providers to treat adults and children hospitalized with severe covid‑19. severe covid‑19 is defined as patients with an oxygen saturation (spo2) <= 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ecmo), a heart–lung bypass machine. distribution of remdesivir under the eua was controlled by the us government for use consistent with the terms and conditions of the eua. gilead supplied remdesivir to authorized distributors, or directly to a us government agency, who distributed it to hospitals and other healthcare facilities as directed by the us government, in collaboration with state and local government authorities, as needed. gilead stated they were donating 1.5 million vials for emergency use and estimated, as of april 2020, they had enough remdesivir for 140,000 treatment courses and expect to have 500,000 courses by october 2020, and one million courses by the end of 2020. the initial distribution of the drug in the us was tripped up by seemingly capricious decision-making and finger-pointing, resulting in over a week of confusion and frustration among health care providers and patients alike. on 9 may 2020, the united states department of health and human services (hhs) explained in a statement that it would be distributing remdesivir vials to state health departments, then would allow each department to redistribute vials to hospitals in their respective states based upon each department's insight into "community-level needs." hhs also clarified that only 607,000 vials of gilead's promised donation of 1.5 million vials would be going to american patients. however, hhs did not explain why several states with some of the highest caseloads had been omitted from the first two distribution rounds, including california, florida, and pennsylvania. in may 2020, gilead indicated they would increase the number of doses donated to the us from 607,000 to around 940,000. some of the initial distribution was sent to the wrong hospitals, to hospitals with no intensive care units, and to facilities without the needed refrigeration to store it. in june 2020, hhs announced an unusual agreement with gilead in which hhs agreed to gilead's wholesale acquisition price, hhs would continue to work together with state governments and drug wholesaler amerisourcebergen to allocate shipments of remdesivir vials to american hospitals through the end of september 2020, and in exchange, during that three-month timeframe (july, august, and september), american patients would be allocated over 90% of gilead's projected remdesivir output of more than 500,000 treatment courses. absent from these announcements was any discussion of allocation of remdesivir production to the approximately 70 countries omitted from gilead's generic drug licensing agreements—including much of europe and countries as populous as brazil, china, and mexico—or the 127 countries listed on those agreements (during the time it will take for gilead's generic licensees to ramp up their own production). as the implications of this began to sink in, several countries publicly confirmed the next day that they already had adequate supplies of remdesivir to cover current needs, including australia, germany, and the united kingdom. in august 2020, the fda broadened the emergency use authorization (eua) for remdesivir to include all hospitalized patients with suspected or laboratory-confirmed covid‑19, irrespective of the severity of their disease. the fact sheet was updated to reflect the new guidance. in october 2020, gilead and hhs announced that hhs was relinquishing control over remdesivir allocation because production of the drug had finally caught up with us domestic demand. amerisourcebergen will remain the sole distributor of veklury in the us through the end of 2020. on 22 october 2020, the fda approved remdesivir and also revised the eua to permit the use of remdesivir for treatment of suspected or laboratory confirmed covid‑19 in hospitalized children weighing 3.5 kilograms (7.7 lb) to less than 40 kilograms (88 lb) or hospitalized children less than twelve years of age weighing at least 3.5 kilograms (7.7 lb). this decision was criticized for an alleged lack of previous consultation on part of the fda given the complications of antiviral drug issues. in november 2020, the fda issued an eua for the combination of baricitinib with remdesivir, for the treatment of suspected or laboratory-confirmed covid‑19 in hospitalized people two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo). the data supporting the eua for baricitinib combined with remdesivir are based on a randomized, double-blind, placebo-controlled clinical trial (actt-2), which was conducted by the national institute of allergy and infectious diseases (niaid). the eua was issued to eli lilly and company. remdesivir received approval from the us food and drug administration (fda) in october 2020, for use in adults and children twelve years and older requiring hospitalization for treatment of severe covid‑19 infections. in january 2022, the fda gave regulatory approval to remdesivir for use in adults and children (twelve years of age and older who weigh at least 40 kilograms (88 lb) and are positive for covid‑19, not hospitalized, and are ill with covid‑19 having high risk for developing severe covid‑19, including hospitalization or death. the fda also provided emergency use authorization in 2022, for remdesivir treatment of children under age twelve who are covid-positive and not hospitalized, but have mild-to-moderate covid‑19 with high risk of developing severe infection, including hospitalization or death. economics in june 2020, gilead announced that it had set the price of remdesivir at us$390 per vial for the governments of developed countries, including the united states, and us$520 for us private health insurance companies. the expected course of treatment is six vials over five days for a total cost of us$2,340. being a repurposed drug, the minimum production cost for remdesivir is estimated at us$0.93 per day of treatment. in july 2020, the european union secured a €63 million (us$74 million) contract with gilead, to make the drug available there in early august 2020. in october 2020, gilead sciences and the european commission announced they had signed a joint procurement framework contract in which gilead agreed to provide up to 500,000 remdesivir treatment courses over the next six months to 37 european countries. among the contracting countries were all 27 eu member states plus the united kingdom, "albania, bosnia & herzegovina, iceland, kosovo, montenegro, north macedonia, norway, and serbia". at the time, the price per treatment course was not disclosed; reuters reported the price was 2,070 euros, thereby implying the total value of the contract (if all 500,000 courses are ordered) is approximately €1.035 billion. under the contract, each participating country will directly place orders with gilead and pay gilead directly for its own orders. names remdesivir is the international nonproprietary name (inn) while the development code name was gs-5734. research remdesivir was originally created and developed by gilead sciences in 2009, to treat hepatitis c and respiratory syncytial virus (rsv). it did not work against hepatitis c or rsv, but was then repurposed and studied as a potential treatment for ebola virus disease and marburg virus infections. according to the czech news agency, this new line of research was carried out under the direction of scientist tomáš cihlář. a collaboration of researchers from the centers for disease control and prevention (cdc) and gilead sciences subsequently discovered that remdesivir had antiviral activity in vitro against multiple filoviruses, pneumoviruses, paramyxoviruses, and coronaviruses. preclinical and clinical research and development was done in collaboration between gilead sciences and various us government agencies and academic institutions. during the mid-2010s, the mintz levin law firm prosecuted various patent applications for remdesivir on behalf of gilead sciences before the united states patent and trademark office (uspto). the uspto granted two patents on remdesivir to gilead sciences on 9 april 2019: one for filoviruses, and one which covered both arenaviruses and coronaviruses. ebola in october 2015, the united states army medical research institute of infectious diseases (usamriid) announced preclinical results that remdesivir had blocked the