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The U.S. Food and Drug Administration just gave the green light to a promising monoclonal antibody therapy co-developed by Canadian scientists for the treatment of mild to moderate coronavirus infections – an innovative product that has not yet been approved by Health Canada for use in this country.
The antibody treatment, called bamlanivimab, has produced positive results in clinical trials and reduced the severity of COVID-19 in patients with underlying health conditions (such as diabetes, chronic kidney disease, obesity, or the age of 65), while also reducing hospitalization rates.
US data shows that people with comorbidities – two or more medical conditions at the same time – are much more likely to die from COVID-19. This drug could help reduce those death rates.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight harmful antigens such as viruses. Bamlanivimab is specifically designed to prevent the SARS-CoV-2 virus from attaching to human cells.
The antibody in question, LY-CoV555, was discovered by scientists from Vancouver-based AbCellera in collaboration with the National Institute of Allergy and Infectious Diseases Vaccine Research Center (VRC). The treatment was developed in collaboration with US pharmaceutical giant Eli Lilly.
“This is a game changer in the sense that it can intervene at a critical point in the disease to prevent it from progressing to a more dangerous stage, especially for high-risk patients,” Dr. Doron Sagman, vice president for research and Eli Lilly Canada’s development and medical affairs, he told CBC News.
“We hope it can make a significant contribution … as a bridge to vaccines,” Sagman said, adding that such therapies will still be needed after a vaccine is released.
“Some people, especially those who are immunocompromised or the elderly, may not have a complete and robust response to vaccines. So it will be very important.”
While clinical data was submitted to US and Canadian regulatory authorities for approval around the same time in early October, Health Canada said it was not yet ready for the drug’s approval and its process of approval. continuous review.
“Health Canada is committed to reviewing COVID-19 drugs and vaccines quickly. However, our top priority is to provide Canadians with access to safe, high-quality, and effective drugs and vaccines,” a spokesperson for the department said. .
“Although Health Canada has received some applications, all the necessary data to support a vaccine or treatment approval has not yet been received. The decision on vaccine and treatment approval will be made based on the evidence presented by sponsors. “.
Sagman said Eli Lilly has provided data on the drug to Health Canada using the agency’s new ongoing review process, which allows companies to submit clinical trial results as they become available. This process allows drug manufacturers to squeeze the long lead times they normally face when bringing a new product to market.
“We have been actively discussing that regulatory process with Health Canada,” Sagman said, adding that distribution of the drug is on hiatus here until Health Canada makes its decision.
“We are working with governments around the world to ensure a fair and transparent allocation of a limited supply for those who need it. It will be difficult to meet the needs of the entire world population, but we will do what we can.”
This summer, the US government reached a $ 375 million deal with Eil Lilly to provide approximately 300,000 vials of the antibody treatment. The company will begin fulfilling those orders now that the FDA has given the green light. The U.S. approval of the treatment is a welcome development for a country that publishes a record number of COVID-19 cases every day.
Canada has not yet negotiated such a purchase agreement, Sagman said, but “there will be opportunities for the government” to enter into a similar wholesale purchase agreement if and when Health Canada signs up for the therapy.
A spokesperson for the company said it plans to supply up to 1 million doses of bamlanivimab to the global market by the end of 2020, with millions more to follow next year.
Doctors at Walter Reed Military Medical Center prescribed a similar antibody cocktail from another company, Regeneron, to US President Donald Trump when he contracted the virus in October. At the time, monocolonal treatment was considered experimental and was not licensed for use on most patients.
Trump touted the drug regime as a “cure”. It isn’t, but some scientists have said the treatment could significantly reduce the stress on health systems by reducing the number of hospitalizations.
The drug reduced the rate of hospitalization and emergency room visits among patients at high risk of disease progression, Eli Lilly said when he published his findings in the New England Journal of Medicine.
Among patients at high risk of disease progression, hospitalizations and emergency room visits occurred on average in only 3% of bamlanivimab-treated cases, compared with 10% in placebo-treated patients, the FDA said in the release. of the Emergency User Authorization (EUA) Monday.
“What we have learned is that it is important to take action early to reduce the viral load before it progresses to a more advanced inflammatory stage that requires hospital interventions,” Sagman said. “This should be given as soon as possible after a COVID-19 test.”
Authorizing treatment “provides healthcare professionals at the forefront of this pandemic with another potential tool in treating COVID-19 patients,” said Dr. Patrizia Cavazzoni, interim director of the Center for Drug Evaluation and Research of the FDA.
The US regulator said the treatment, which is delivered via intravenous injection in a healthcare setting, should only be used on patients in the early stages of infection because the treatment “may be associated with worse clinical outcomes” for people who are already to hospital for complications related to COVID-19.
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