European Union health body recommends remdesivir to fight COVID-19
29 Juin, 2020, 14:21 | Auteur: Yves Courtet
Remdesivir was reviewed in record time by the CHMP under its rolling review procedure, which allows data on a drug to be reviewed as it becomes available.
Since then, another phase 3 trial has shown that a five-day treatment course with remdesivir on top of standard care was more effective than standard care alone in moderately-ill patients, although strangely a 10-day course wasn't any better. Along with Delhi and Maharashtra, Gujarat, Tamil Nadu and Telangana will receive the first batch of the drug that has been named COVIFOR.
The company is sure about enough stock to provide to the present requirements of the drug. "With this Covifor drug, we hope to lessen the treatment time of patients within the hospital, decreasing the increasing pressure on the medical foundation that's now overburdened because of a sudden acceleration in COVID- 19 infection rates". It would be available in both government and private hospitals. The cost of the product is Rs 5,400 per bottle.
The other lot will be supplied to Kolkata, Indore, Bhopal, Lucknow, Patna, Bhubaneshwar, Ranchi, Vijayawada, Cochin, Trivandrum and Goa within a week, it added.
The patient will be given an intravenous injection of 200 mg on the first day and then 100 mg IV 5 days a day. This drug should not be prescribed to pregnant or nursing mums and minors under 12 years old.
The EMA endorsement means physicians can prescribe the Gilead drug in Europe once the European Commission, the EU executive, gives its approval, which is now a formality expected over the coming week. While the drug is being manufactured at the company's formulation facility in Hyderabad, the active pharmaceutical ingredient (API) is being made in the company's Visakhapatnam facility.
In May, domestic pharma firms Hetero, Cipla and Jubilant Life Sciences entered into non-exclusive licensing agreements with drug major Gilead Sciences Inc for manufacturing and distribution of remdesivir.
It said its assessment was based mainly based on data from a study sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID).
The CHMP has recommended granting a conditional marketing authorisation to remdesivir under the Veklury brand name - the same used for the drug in Japan where it has approval under emergency use protocols.
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