Remdesivir gets FDA nod
Drug gets approval for use in adults, paediatric patients of 12 years and above and weighing more than 40 kg for Covid treatment
Hyderabad: The broad-based anti-viral drug Remdesivir meant for Covid-19 positive patients has become the first treatment to be approved by the US Food and Drug Administration (USFDA).
The FDA approval comes close on the heels of the Solidarity Trial of World Health Organisation (WHO) and Indian Council of Medical Research (ICMR), which said that the anti-viral drug had little or no effect on overall mortality and duration of hospital stay in patients.
The opposing views on Remdesivir from USFDA and WHO has managed to sow seeds of doubt and confusion among general public. Clinicians from Hyderabad, who are personally treating Covid-19 positive patients, however, point out that the answer over effectiveness of Remdesivir might lie somewhere in between.
A lot depends on when or at what stage the antiviral drug was administered to patients. “Timing of administering Remdesivir drug appears to be very important. If you use the drug at the right time on positive patients, then they recover. However, if you lose that narrow window, then the drug will be of no use and will unnecessarily become a financial burden on the patient,” says Superintendent, Gandhi Hospital, Dr M Raja Rao.
The USFDA has approved Remdesivir for use in adults and paediatric patients of 12 years and above and weighing more than 40 kg for treatment of Covid-19. The ICMR and WHO tested four drugs including Remdesivir, Interferon β1a, Lopinavir/Ritonavir and Hydroxychloroquine (HCQ). “Interim analysis showed that no benefits of Remdesivir in any groups of Covid-19 asymptomatic/mild/moderate/severe/critical) patients,” ICMR said.
In May/June, Remdesivir emerged as a vital antiviral therapeutic, especially for Covid-19 patients with breathing difficulties and those with lung damage. It continues to remain a go-to drug for doctors in public and private hospitals involved in treatment of Covid patients.
“Solidarity trial confirms what we already suspected. Remdesivir doesn’t have overall mortality benefit in hospitalised patients. It may have a role in reducing mortality in certain subset of hospitalized patients – not on oxygen or on low flow oxygen but definitely not on those on high-flow or those on ventilator. Remdesivir seems to have benefit in early symptom improvement and recovery time in moderately affected hospitalised patients in our clinical experience,” says senior Infectious Disease expert, Apollo Hospitals, Dr Suneetha Narreddy.
Due to the hype, there is a lot of demand for Remdesivir from patients who are receiving treatment at private and government hospitals. A single vial of Remdesivir costs Rs 5,000 and it is only available in Covid-19 designated hospitals and not in drug stores.
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