Five Indian States To Receive Coronavirus Drug
Gilead Sciences will begin human trials of an inhaled version of remdesivir this week.
India's drug regulator has given Hetero Labs and Cipla Ltd the green light to manufacture and market their generic version of Gilead Sciences Inc's experimental COVID-19 treatment remdesivir, the Indian pharmaceutical companies said on Sunday.
"If the trials are successful, this could represent important progress".
Remdesivir is now given to patients intravenously through daily infusions in hospital.
An inhaled formulation would be administered via a nebuliser, potentially allowing for easier administration outside of the hospital setting, and at earlier stages of disease.
Last week, Gilead announced it is about to start advanced trials of the drug in children.
Coronavirus: Melbourne schools undergo deep cleaning as new COVID cases emerge
On Sunday, another 49 cases of coronavirus were announced , taking the state's total number of cases to more than 2,000. Six of the new cases are believed to be from community transmission, health minister Jenny Mikakos said today.
In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States. Remdesivir is now being used to treat patients through emergency use authorizations and other access programs around the world. Remdesivir was being developed as a treatment for Ebola, but recent trials found it effective against COVID-19.
"Taking into account the available data, the Agency believes that the risks and benefits was positive in patients with pneumonia who need supplemental oxygen, and patients with severe diseases", - said in a statement.
Daniel O'Day, Chairman and Chief Executive Officer of Gilead, said that as part of this next wave of clinical development, the company will study remdesivir in treating COVID-19 earlier in the disease and in combination with other therapies. The preliminary report was based on data obtained from the Adaptive COVID-19 Treatment Trial (ACTT), a double-blind, randomized, placebo-controlled trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
So far, the only drug that has reduced mortality in COVID-19 is dexamethasone, a low-priced generic steroid that cut the death rate for the most seriously-ill patients by 41% at 28 days in the large-scale RECOVERY trial.
"The remdesivir is the first drug against the Covid-19 to be recommended for authorisation in the EU", said in a statement that the agency based in The Hague, adding that this recommendation must now be approved or not by the european Commission.
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