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Researchers and health experts are looking at all possibilities available to find a cure for the coronavirus infection. While trials of more than 150 COVID-19 vaccine candidates are underway across the world, some existing drugs are also being tested and used for the treatment of the viral infection. Remdesivir is one of the much-touted drugs for COVID-19 treatment. The antiviral drug originally developed to treat Ebola has been approved by the Drug Controller General of India (DCGI) for "restricted emergency use" on severely ill hospitalised coronavirus patients. It is also the only drug approved by the United States Food and Drug Administration (USFDA) for Emergency Use Authorisation (EUA) treatment of adult and pediatric patients hospitalised with suspected or laboratory-confirmed COVID-19 infection. Remdesivir is currently available in an injectable form. But Gilead Sciences the patent holder of the drug is developing an inhaled version of remdesivir to treat coronavirus patients in the outpatient setting.
The US-based company has launched a Phase Ia clinical trial of the inhaled version to evaluate the safety, tolerability and pharmacokinetics of the new formulation. The randomised, placebo-controlled study will involve 60 healthy participants aged 18-45. It is believed that SARS-CoV-2 infects the upper respiratory tract in the early stages of the disease. The new formulation will enable direct delivery of remdesivir to the primary site of infection with a nebulised, inhaled solution. This approach may enable easier administration outside the hospital as well as lower systemic exposure to the drug, the company said.
If Phase Ia trial turns out successful, the company will next conduct a clinical study of the inhaled formulation in COVID-19 patients whose infection has not progressed to hospitalisation. With clinical trials of intravenous remdesivir showing promising results in hospitalised patients, Gilead Sciences now wants to investigate the drug's potential in the outpatient setting.
The US Food and Drug Administration (FDA) last month granted permission to Gilead Sciences to investigate the inhaled version of remdesivir in human clinical trials. Trials of remdesivir in combination with anti-inflammatory drugs, in vulnerable patient populations, and in outpatient settings are also underway.
Indian pharma major Cipla has launched the generic version of remdesivir under the brand name Cipremi and is priced at 4,000 per 100 mg vial. The company is looking to supply over 80,000 vials within the first month. However, it will be available through government and hospital channels only, the company said in an e-mailed statement to PTI.
Cipla, Hetero and Mylan NV have been given approval by DCGI to manufacture and sell generic versions of remdesivir in India. Hyderbad-based Hetero will sell its generic version of Remdesivir under the brand name 'Covifor' in India. It has fixed a maximum retail price of 5,400 per vial for the drug.
Mylan NV is also launching Remdesivir under brand name DESREMTM in India at Rs 4,800 per 100 mg vial this month.
In May, Gilead Sciences had signed non-exclusive voluntary licensing agreements with five domestic generic pharma companies Cipla, Jubilant Life Sciences, Hetero, BRD and Mylan for production and sale of remdesivir.