(Reuters) – Doctors in Europe will soon be able to treat COVID-19 patients with Gilead (GILD.O), antiviral drug, remdesivir, after the support of the health regulator set it on the path to becoming the first therapy for the disease on the continent.
FILE PHOTO: Pharmaceutical company Gilead Sciences Inc is seen after announcing a phase 3 trial of the investigational antiviral drug Remdesivir in patients with severe coronavirus disease (COVID-19), during the outbreak of coronavirus disease (COVID -19), in Oceanside, California, USA, April 29, 2020. REUTERS / Mike Blake / File Photo
The European Medicines Agency (EMA) said Thursday that its Human Medicines Committee (CHMP) recommended conditional approval of the medicine for adults and adolescents aged 12 and older who also suffer from pneumonia and require oxygen. (bit.ly/3i3O6Ck)
The European Union conditional marketing authorization allows a treatment to be sold for one year in the 27-nation bloc before all necessary data on its efficacy and side effects are available. Gilead has until December to send this data.
EMA’s endorsement means that doctors can prescribe the drug Gilead in Europe once the European Commission, the EU executive, gives its approval, which is now a formality expected next week.
The European price of the drug is not yet known. In the United States, a research group suggests that remdesivir can be priced at up to $ 5,080 per course, while Indian generic drug makers will sell the treatment from Rs 5,000 to Rs 6,000 ($ 66.13- $ 79.35).
United States-based Gilead, whose shares have risen 17% this year on hopes of treatment, in an emailed statement said it has not yet set a price.
Demand for the drug skyrocketed after the COVID-19 trials showed promise, but supply could be a problem.
Italy’s drug agency AIFA said it was in talks with Gilead at the national and EU levels about the doses, adding that talking about the price “is premature now.”
“This situation is very atypical, so we must assume that it will be the EU, which enters and negotiates with Gilead on a certain amount,” said the Danish public drug procurement office.
Gilead expects it will be able to provide more than two million Veklury-branded remdesivir courses by the end of the year, double its previous goal.
The drug maker also plans to try a more user-friendly inhaled version of the drug that is now given intravenously.
Remdesivir is designed to prevent certain viruses, including the new coronavirus, from making copies of themselves and potentially potentially overwhelming the body’s immune system. The drug previously failed in trials as an Ebola treatment.
Remdesivir has been approved for emergency use in seriously ill patients in the United States, India, and South Korea, and has received full approval in Japan.
($ 1 = 75.6105 Indian rupees)
Report by Pushkala Aripaka in Bangalore; Additional reports by Manas Mishra, Emilio Parodi and Nikolaj Skydsgaard; Editing by Arun Koyyur and Barbara Lewis / Emelia Sithole-Matarise
.
