The UK approves the Regeneron / Roche antibody cocktail for COVID-19

August 20 (Reuters) – UK drug regulator has approved an antibody cocktail developed by Regeneron (REGN.O) and Roche (ROG.S) to prevent and treat COVID-19, it said on Friday, while the nation fights growing hospitalizations due to the more infectious Delta variant.

The Agency for the Regulation of Medicines and Health Products (MHRA) said data from clinical trials show that the drug Ronapreve could help prevent infection, help resolve the symptoms of severe COVID-19 infection and reduce the chances of hospitalization.

“This treatment will be a significant addition to our armory to combat COVID-19,” British Health Minister Sajid Javid said in a statement.

The news comes when hospitalizations of patients with COVID-19 exceeded 6,100 this week, a maximum of five months. Two-thirds of hospitalized patients were not vaccinated, according to data shown earlier this month.

Ronapreve, known as REGEN-VOC in the United States, can be taken by injection or infusion. It binds strongly to the coronavirus in the lining of the respiratory system and prevents it from gaining access to the cells of the respiratory system, the MHRA said.

Ronapreve belongs to a class of medicines called monoclonal antibodies that mimic the natural antibodies produced by the body to fight infections. The drug is not intended to be used as a substitute for vaccination, the MHRA said.

Javid said the government would start deploying therapy across the NHS as soon as possible.

It is the third therapy in the UK arsenal, in addition to the generic dexamethasone and the drug tocilizumab for arthritis, sold by Roche as Actemra and RoActemra.

Earlier this week, Roche warned of the global shortage of arthritis drugs that will last a few more weeks. Read more

Ronapreve / REGEN-COV received emergency approval to treat COVID-19 in more than 20 countries, including the United States, which has also authorized similar treatment by Eli Lilly (LLY.N) for COVID patients -19 not hospitalized. Read more

It has been a big winner for Regeneron, which posted U.S. sales of $ 2.59 million in the second quarter. Read more

In June, the European Union purchased some 55,000 doses of the treatment while the region’s drug watcher reviews the drug for approval.

Reports of Muvija M and Sachin Ravikumar in Bengaluru and Josephine Mason in London; edited by Jason Neely, Elaine Hardcastle

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