The EMA cited a clinical trial of more than 1,000 patients hospitalized with COVID-19.
According to a preliminary report from the ACTT-1 (Adaptive COVID-19 Treatment Trial 1) study1, a randomized clinical trial conducted with remdesivir in 1063 patients over 60 centres across U.S., Europe and Asia demonstrated a faster time to clinical recovery in hospitalised patients as compared to placebo.
The statement quoted Hetero Group of Companies Managing Director Dr M Srinivasa Reddy as saying that through this drug, the company hopes to reduce the time it takes to treat a COVID-19 patient in a hospital, so that the mounting pressure on the medical authorities could be reduced. This drug is indicated for use in early to moderate COVID-19 patients.
Cipla shares towered over 9 percent to hit a career-high on Monday after the company informed stock exchanges that it had received approval from the government's Drug Controller General of India (DCGI).
Five states across India will be the first to receive Hetero Healthcare's COVID-19 drug, COVIFOR, the first generic brand of the experimental drug remdesivir.
"Taking into account the available data, the Agency believes that the risks and benefits was positive in patients with pneumonia who need supplemental oxygen, and patients with severe diseases", - said in a statement.
The assessment ended with recommendations that are mainly based on survey data NIAID-ACTT-11 sponsored by the National Institute of Allergy and infectious diseases of the United States, as well as on data of other studies on ramdevpir. "We will also conduct trials using intravenous infusions in outpatient settings such as nursing homes", said Daniel O'Day, CEO, Gilead Sciences.
The company has priced the drug at Rs 5,400 per vial.
Research on the drug was first started by Gilead in 2009 with research programs for the treatment of hepatitis C (HCV) and respiratory syncytial virus (RSV) and its antiviral profiling was done in 2013 and early 2014-that suggested its broader antiviral potential.
Demand for the drug soared after it became a front-runner following promising trials.