Week's news analysis

Gilead upshifts its strategy
against Covid-19 with remdesivir

PHARMAnetwork studies - uptated 10 July 2020

In the race to find either a treatment or a vaccine to fight the Covid-19 pandemic, Gilead obtains accurate results. As time goes by, there is more evidence that its Remdesivir product, originally indicated against Ebola fever, can also help moderately ill patients.

In June, the results from a phase III clinical trial showed that coronavirus patients who were hospitalized, but not sick enough to need oxygen from a ventilator, were more likely to recover after a five-day course of Remdesivir, than those given the current standard of care alone, Gilead said. The study demonstrated that patients in the 5-day Remdesivir treatment group were 65 % more likely to have clinical improvement at day 11 compared with those in the standard of care group. End of April, in another trial, Gilead Sciences announced that patients prescribed its recovered 31% faster than patients who received a placebo.

As a result, in various parts of the world, Remdesivir has more and more been used to treat patients with Covid-19: in the United States, the Food and Drug Administration issued in early May an Emergency Use Authorization; in Asia, Remdesivir is approved to treat the disease in Japan. In Europe, the EMA has put it under rolling review in April, and recommended conditional approval in June, making it the first medicine against the disease to be backed for authorisation in the European Union.

If it is clear that the drug does not cure the infection, it is also clear that its widespread use makes possible to free up hospital beds and help destress medical systems, like in the United States. The UK health service also made it available for emergency use in patients hospitalized with severe cases, according to a May 26 statement.

Moreover, the California-based company is working on extending the treatment earlier in the course of disease, and in combination with other therapies, for the most critically ill patients. Trials already under way include evaluating Remdesivir with Eli Lilly's JAK inhibitor Olumiant (baricitinib) and with Roche's IL-6 inhibitor Actemra/RoActemra (tocilizumab), with results from these anticipated over the coming months.

Gilead Sciences also hopes to start clinical trial this summer evaluating an inhaled formulation of Remdesivir, administered via a nebuliser, to patients with Covid-19. This new formulation could allow for administration of the drug outside hospitals and at earlier stages of the disease.

To ensure sufficient worldwide supply, the company signed in May several deals to build out a global network of manufacturers and distributors for its drug. The latest deal was signed with indian company, Dr Reddy's Laboratories. It gives it the right to register, manufacture and sell Remdesivir in 127 countries, including India. Elsewhere, Gilead has also signed "non-exclusive voluntary licensing agreements" with a number of generic drugmakers, such as Mylan, Cipla, Eva Pharma, Ferozsons Laboratories, Hetero Labs, Jubilant Life Sciences, Syngene International, Zydus Cadila Healthcare, in India, Pakistan and Egypt. Each company can set its own price for generic Remdesivir, meanwhile Gilead has not yet disclosed its own price. Companies will not pay any royalties until an end to the pandemic is declared.

End of June, the company disclosed that Remdesivir will be priced at $390 per vial in the United States and other developed countries, with a five-day treatment course of six vials costing $2 340 per patient. The price is specifically for government entities, while in low and lower-middle income countries, the treatment will be delivered at lower cost.

That is why, in the meantime, preliminary results of the "Recovery" study from the University of Oxford suggesting that low-dose of the cheaply produced steroid dexamethasone was likely to reduce the risk of death by up to one third in hospitalised patients with severe respiratory complications, who required oxygen treatment, are closely watched. More detailed results showed that among patients in the standard-care arm, 28-day mortality was 41 % in those who required ventilation, 25% in those who required oxygen only and 13% for patients who did not require any respiratory intervention. Patients treated with dexamethasone had 28-day mortality rate lowered by 17%, with a highly significant trend showing greatest benefit among those patients requiring ventilation. Dexamethasone reduced deaths by 35% among intubated patients and by 20% in those receiving oxygen only.

PHARMAnetwork magazine - Edition 45| Read...
Go to Top