India has approved a new treatment for Covid-19 patients — a cocktail of two antibodies that has been shown in trials to reduce hospitalisation or death by 70 per cent compared with those who did not get the cocktail.

Roche India, the Indian arm of the Swiss pharmaceuticals company, announced on Wednesday that the Central Drugs Standard Control Organisation, the country’s drug regulatory authority, has granted an emergency use authorisation to the cocktail of casirivimab and imdevimab.

The EUA will enable Roche to import the globally manufactured product batches to India where it will be marketed and distributed by the Indian company Cipla, Roche said.

The antibody cocktail, approved by the US Food and Drug Administration in November 2020, is intended for the treatment of patients with mild to moderate Covid-19 and seeks to prevent their condition from worsening, Roche said.

The company had in March this year announced the results of a large global trial involving over 4,500 high-risk hospitalised Covid-19 patients that had found that the antibody cocktail significantly reduced the risk of hospitalisation or death by 70 per cent in relation to those who received placebo.

The antibody cocktail also shortened the duration of symptoms by four days, Roche said.

Amid India’s still rising second Covid-19 wave — and over 3.48 million active patients on Wednesday — the company signalled that the initial local demand may “far exceed” the supplies that the company will be able to provide.

“It is too early to say what specific amounts will be shipped to India,” a Roche spokesperson said. “We’re in discussion with our marketing partner to support access to this treatment for eligible patients.”

The company also declined to specify the price of the product in India. “There will be differential pricing and the cost in India is likely to be among the lowest in the world,” the spokesperson told The Telegraph.

Roche had said in January this year that it is collaborating with the US company Regeneron to increase the global supply of casirivimab and imdevimab with the aim to have more than two million doses available annually. Roche will be responsible for development and distribution outside the US.

The US government had announced in January this year that it would purchase up to 1.25 million doses of the antibody cocktail and make them available “at no cost to patients”, though healthcare facilities could charge fees related to administration.

Casirivimab and imdevimab are so-called monoclonal antibodies specifically directed against the spike protein of the novel coronavirus and designed to block entry of the virus into human cells.

Roche said the antibody cocktail is to be administered for the treatment of mild or moderate Covid-19 in adults and pediatric patients 12 years or older weighing at least 40kg who are at high risk of developing severe Covid-19.

The US FDA had in November 2020 said casirivimab and imdevimab are not authorised for patients who are hospitalised due to Covid-19 or who require oxygen therapy due to Covid-19. A benefit of the cocktail has not been shown in hospitalised patients, the FDA had said.

The CDSCO has so far approved under emergency use authorisation the antivirals remdesivir and favipiravir and the anti-inflammatory agents called tocilizumab and itolizumab for Covid-19 treatment.