WHO back Regeneron COVID-19 drug cocktail, but calls for access and reduction on price

The Regeneron antibody-drug cocktail – casirivimab and imdevimab – has been added to the World Health Organization’s (WHO) list of treatments for people with COVID-19, the UN agency said on Friday, before underscoring the need for lower prices and equitable distribution.

“This is a major breakthrough in the care of COVID-19 patients” said Dr Janet Diaz, WHO head of clinical care. “This is our first recommendation for a therapeutic for those patients with mild, moderate disease,” she said, because it reduces “the need for hospitalisation if they are at high risk”.

WHO’s conditional recommendations are for use of the drug combination on patients who were not severely ill but at high risk of being admitted to hospital with COVID-19, or those with severe cases of the disease and no existing antibodies.

“Giving them this additional antibody seems to show an effect. And what effect is that? A reduction in mortality” Dr Diaz told a briefing in Geneva.

The antibody therapy was granted emergency use authorization in the United States November last year after it was used to treat former President Donald Trump when he was admitted to hospital with COVID-19.

The United Kingdom has also approved Regeneron, while it is under review in Europe. The WHO recommendations were largely based on data from a British study of 9,000 patients in June which found that the therapy reduced deaths in hospitalised patients whose own immune systems had failed to produce a response.

“We are taking the information (from the UK study) and generalizing it to other persons,” said Dr Diaz. “We saw there was a benefit we thought was meaningful.” The treatment has been on the market for decades to treat many other diseases, including cancers. It is based on a class of drugs called monoclonal antibodies which mimic natural antibodies produced by the human body to fight off infections.

Swiss drugmaker Roche has been working in partnership with Regeneron, which holds the patent, to produce the antibody treatment. Dr Diaz urged Regeneron to lower the drug’s price and work on equitable distribution worldwide: “We know that the life-saving benefits and the benefits for patients with COVID-19 is significant and requires action.” Dr Diaz added that UNITAID, an international health agency, was negotiating directly with Roche for lower prices and equitable distribution across all parts of the world, “including low and middle-income countries”.

WHO has also been in discussions with the company for a donation and distribution of the drug through UN Children’s Fund UNICEF, following an allocation criteria set by the health agency. “We are working together with the company so we can address these very important issues so we can have equitable access” she said.

In a statement, WHO said in parallel it had “launched a call to manufacturers who may wish to submit their products for pre-qualification, which would allow for a ramping-up of production and therefore greater availability of the treatment and expanded access. ACT-A partners are also working with WHO on an equitable access framework for recommended COVID-19 therapeutics”. On that subject, Dr Diaz added that “there are bottlenecks and we are aware of those. WHO has launched the pre-qualification expression of interest call so that the manufacturing companies can start to submit their dossiers to WHO”.

ends

STORY: Regeneron COVID-19 Treatment - WHO

TRT: 2’18’’

SOURCE: UNTV CH

LANGUAGE: ENGLISH

ASPECT RATIO: 16:19

DATELINE: 24 Sept 2021, GENEVA, Switzerland

SHOTLIST

1. Exterior wide shot, United Nations flag alley.

1. Wide shot, inside the bi-weekly press conference room, participants.

1. SOUNDBITE (English): Dr Janet Diaz, Head of Clinical Care, World Health Organization (WHO): “So this is a major breakthrough in the care of COVID-19 patients, we have expanded our tools to treat patients with covid-19 and this is our first recommendation for a therapeutic for those patients with mild, moderate disease because of the risk of reducing the need for hospitalization if they are at high risk.”

1. Medium shot, participant attending the press briefing.

1. SOUNDBITE (English): Dr Janet Diaz, Head of Clinical Care, World Health Organization (WHO): “The first recommendation is a conditional recommendation for use in patients who have non severe COVID-19, so those are patients that are mild or moderate and can be seen in the outpatient setting, but it's on the condition that patients are at the higher risk for severe disease. So not for all the patients, but those at the highest risk.”

1. Medium shot, participant attending the briefing.

1. SOUNDBITE (English): Dr Janet Diaz, Head of Clinical Care, World Health Organization (WHO): “The second recommendation is a conditional recommendation for patients with severe and critical COVID-19, so those are the sicker patients in the hospital on oxygen, on corticosteroids. The condition here is for those patients that are sero-negative. That means on a serology test at that moment, they have not yet mounted their own antibody response. So giving them this additional antibody seems to show an effect. And what effect is that? A reduction in mortality.”

1. Wide shot, speakers at podium and briefing broadcast on large-screen TV.

1. SOUNDBITE (English): Dr Janet Diaz, Head of Clinical Care, World Health Organization (WHO): “It is true right now there's limited availability and the cost is high for this monoclonal antibody cocktail. However, with this new recommendation, we know that the life-saving benefits and the benefits for patients with COVID-19 is significant and requires action.”

1. Medium shot, participant attending the briefing, podium speaker to rear.

1. SOUNDBITE (English): Dr Janet Diaz, Head of Clinical Care, World Health Organization (WHO): “At this time, through the ACT aid mechanism UNITAID is negotiating directly with Roche pharmaceutical companies about manufacturing drugs for lower prices, as you have just described, is very important and equitable distribution across all the regions, including low and middle-income countries.”

1. Wide shot, briefing room, the three main speakers of the briefing.

1. Medium shot, participants in foreground and to rear.

1. Wide shot, press briefing room.