EMA gives 'thumbs up' for GSK Covid-19 treatment sotrovimab

The European Medicines Agency's Committee for Human Medicinal Products issued a 'positive scientific opinion' for the Covid-19 treatment developed by GlaxoSmithKline and Vir Biotechnology, sotrovimab.

Christopher Corsico, senior vice president, Development, at GSK, said: "As the COVID-19 pandemic continues and the virus generates new variants of concern, including those that recently emerged in India, the need for therapies that can slow the progression of disease in patients who are at high risk for developing severe complications remains a top priority."

The results of a phase three clinical trial with 583 participants had revealed an 85% reduction in hospitalisation or death.

Several in-vitro studies had also shown that the treatment maintained activity against the variants first detected in Brazil, California, South Africa and the UK.

More recently, in vitro study data showed the treatment was also active against the variants detected in New York and India.

A positive opinion can be used by national health authorities within the bloc when deciding whether to allow its use before it is granted a full EMA marketing authorisation.

Sotrovimab was designed for use in adults and children over 12 weighing more than 40 pounds and who do not require oxygen support, but who are at risk of progressing to severe Covid-19.

As of 1607 BST, shares of GSK were slipping 0.43% to 1,354.2p.