The Food & Drug Administration (FDA) has formally approved Gilead’s remdesivir for COVID-19 treatment in the US. With this, the drug becomes the first to get FDA approval for use against the pandemic disease.
Remdesivir has seen widespread usage since getting emergency-use authorization this year. Recently, the same drug was also used to treat US President Donald Trump after he contracted the Coronavirus earlier in October.
The thumbs-up from FDA means that Gilead Sciences Inc. can now market the benefits of remdesivir, sold under the name “Veklury”, to the health experts. Also, being the first government-approved drug for COVID-19, remdesivir is in pole position to establish itself as the go-to remedy for the disease.
The FDA’s decision came after a drug trial which showed that, in a pool of 1, 062 COVID-19 patients, those who took remdesivir recovered five days before those who took a placebo. The trial also detected side-effects such as nausea and increased production of liver enzymes in the body.
However, the FDA and the World Health Organization (WHO) don’t see eye-to-eye on remdesivir’s potency against the Coronavirus.
The WHO also carried out a trial, comprising of 11, 266 patients across 30 countries, and concluded that the medicine had little to no effect. In retort, Gilead criticized WHO’s findings and emphasized that they don’t nullify other studies that found remdesivir as effective.
During a Bloomberg survey, analysts predicted that the drug’s sales will cross $2.17 billion by the end of 2020. According to Gilead’s June announcement, the drug costs the hospitals $3, 120 for most patients.