Australia approves ‘miracle drug’ Remdesivir as first treatment with COVID-19 used in severe cases of the deadly disease
- The drug has received the green light to become the first approved treatment for COVID-19
- The U.S.-made drug is the only treatment worldwide to receive approval to treat viruses
- Australian health authorities said that Remdesivir could reduce pressure on hospitals
- Therapeutic Goods Administration added that it could speed recovery times
- The drug will only be available to hospitalized Australians who are seriously ill
The American miracle drug Remdesivir has received the green light to become the first approved treatment for COVID-19 in Australia.
The drug – the only major treatment worldwide to receive approval for the new coronavirus since the onset of the pandemic – has received preliminary approval for use in hospitalized patients with severe cases of fatal respiratory disease.
The Therapeutic Goods Administration said in a statement that Remdesivir would reduce the burden on the Australian health care system and help hospital patients recover faster.
“Remdesivir provides an opportunity to reduce pressure on the Australian health care system,” the national therapeutic goods regulator said in a statement.
The American drug Remdesivir has received preliminary approval to become the first approved treatment for COVID-19 in Australia. The drug was shown in a vial in March at a facility in California.
Remdesivir will not be available to Australians unless they are critically ill, need oxygen or need high level support to breathe, and in hospital care.
“While this is a major milestone in Australia’s fight against the pandemic, it is important to emphasize that the product has not been shown to prevent coronavirus infection or alleviate milder cases of infection.”
The TGA said that a “large multidisciplinary review team” worked around the clock to reach a point where it could approve the drug for consumption by the Australian public.
The government department added that the approval based on initial clinical data was provisional – meaning the green light for use in Australia would expire after six years.
The US has already approved the treatment for emergency use, and Japan, Taiwan, India, Singapore, and the United Arab Emirates have approved the treatment for COVID-19 therapy.
The drug’s manufacturer, Gilead Sciences, has come under fire in the US for announcing that even private insurance patients would have to pay US $ 3,120 (AUD $ 4,489) for standard treatment.
A lab technician holds Remdesivir in June at the Eva Pharma Facility in Cairo, Egypt. Authorities hope the drug will reduce the burden on the Australian health care system and extend recovery times of COVID-19
Gilead has priced its product for richer countries at $ 390 (AUD $ 561) per 100mg vial – and has signed licensing agreements with generic manufacturers to make the treatment widely available.
In India, pharmaceutical company Cipla Ltd has priced its generic version of remdesivir, Cipremi, at 4,000 rupees (AUD $ 77) per 100 mg vial.
The Indian drug manufacturer said on Wednesday that their drug is among the lowest-priced versions of the so far globally available COVID-19 treatment.
Pictured: The offices of Gilead Sciences Inc – Remdesivir’s manufacturer – 90 miles south of Los Angeles
A vial of Remdesivir is pictured at a press conference at Eppendorf University Hospital (UKE) in Hamburg, Germany on April 8
Cipla had previously said prices would not exceed 5,000 rupees (AUD $ 96).
Sovereign Pharma, which manufactures and packages the drug for Cipla, said on Tuesday it shipped the first batch.
Nikipil Chopra, CEO of Cipla India, said the company launched Cipremi commercially on Wednesday and aims to deliver more than 80,000 vials within a month.
WHAT IS REMDESIVIR AND DOES IT WORK AGAINST COVID-19?
Remdesivir was developed by Gilead Sciences for the treatment of Ebola, the deadly hemorrhagic fever that started in West Africa in 2014.
Ebola, like COVID-19, is caused by a virus, and scientists have tested Remdesivir to treat coronavirus patients.
Trials produced encouraging results earlier this year when it proved promising for both preventing and treating MERS – another coronavirus – in macaques.
Human studies have produced mixed results.
In a U.S. government-led study, Remdesivir shortened recovery time by 31 percent – an average of 11 days versus 15 days for those who received usual care.
However, according to preliminary results, survival after two weeks of follow-up had not improved. Results after four weeks are expected quickly.
The drug appears to help stop the replication of viruses such as coronavirus and ebola.
It’s not entirely clear how the drug achieves this feat, but it seems to prevent the virus’s genetic material, RNA, from copying itself.
This, in turn, prevents the virus from spreading further into the patient’s body.