It is the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection.
The company also announced in its June 22 letter that it will investigate using remdesivir in COVID-19 patients with less severe symptoms, in the hopes that introducing the drug earlier in the disease may help some people avoid the worst symptoms of respiratory distress and failure. "An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of disease", - Daniel O'Day, Chairman & CEO, Gilead Sciences. As part of a risk management plan, Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients. It also said that the drug will be available in the next 8 to 10 days.
According to the EMA, COVID-19 patients who are in need of supplementary oxygen should be given remdesivir for no more than nine days. The drug would be administered intravenously, it said, and must be done in a hospital, or a critical care setting by a medical practitioner.
The treatment was the first to show improvement in the trails on coronavirus patients who have won approval for emergency use in the severely ill patients in the United States and South Korea and received full approval in Japan.
The research, published in leading journal, the New England Journal of Medicine, in May, showed that injections of remdesivir sped up patient recovery compared with a placebo. Remdesivir was being developed as a treatment for Ebola, but recent trials found it effective against COVID-19. It is important, therefore, to have tools that can work together to fight both aspects of the disease: an antiviral to target the virus itself and another therapy to tackle the inflammatory response.
Remdesivir is now being used to treat patients through emergency use authorisations and other access programmes around the world.
Gilead Sciences is trading at $74.70 per share at the time of publication.