Regeneron gets US go ahead for Covid treatment given to Trump

Donal O'Regan

Reporter:

Donal O'Regan

Email:

donal.oregan@limerickleader.ie

Regeneron gets US go ahead for Covid treatment given to Trump

Regeneron employs over 1,000 in Raheen

REGENERON'S antibody drug given to outgoing US president Donald Trump after he was diagnosed with Covid-19 has been approved in the US.

In September, Regeneron announced it is to create an additional 400 jobs in Limerick to allow it to maximise manufacturing capacity at its New York facility for its Covid-19 antibody drug combination REGN-COV2.

In a statement issued on Saturday evening in America, the leading science and technology company said REGN-COV2 is the first antibody cocktail for Covid-19 to receive Food and Drug Administration (FDA) emergency use authorisation.

The New York Times said REGN-COV2 has shown promise in early studies at keeping the infection in check, reducing medical visits in patients who get the drug early in the course of their disease. 

Regeneron says the clinical evidence from its outpatient trial suggests that REGEN-COV2 has the greatest benefit when given early after diagnosis and in patients who "have not yet mounted their own immune response or who have high viral load". This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors, say Regeneron.

"This FDA Emergency Use Authorisation is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.

"The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of REGEN-COV2. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche."

Initial doses of REGEN-COV2 will be made available to approximately 300,000 patients, with no medication out-of-pocket costs, under U.S. government allocation program.

"REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.

"Data from approximately 800 non-hospitalized patients showed significant reductions in virus levels within days of receiving REGEN-COV2, which were associated with significantly fewer medical visits. This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors.

"We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination. Importantly, we continue to advance our rigorous clinical trial program evaluating the safety and efficacy of REGEN-COV2 for both the treatment and prevention of COVID-19, and we will share new results as available."

In 2015, Regeneron launched its Industrial Operations and Product Supply (IOPS) facility in Raheen Business Park to produce medicines for patients around the world. It employs over 1,000 people locally.