A promising new treatment for COVID-19 authorized by the United States, still under review by Health Canada

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The United States Food and Drug Administration has just given the green light to a promising monoclonal antibody therapy co-developed by Canadian scientists to treat mild to moderate coronavirus infections – a breakthrough product that has yet to be approved by Health Canada for use in that country.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 age over 65) while reducing hospitalization rates. .

U.S. data shows that people with co-morbidities – two or more health conditions at once – are much more likely to die from COVID-19. This drug could help reduce these death rates.

Monoclonal antibodies are lab proteins that mimic the ability of the immune system to fight off 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 at AbCellera in Vancouver in collaboration with the National Institute of Allergy and Infectious Diseases Vaccine Research Center (VRC). The treatment was co-developed with US pharmaceutical giant Eli Lilly.

“This is a game-changer in that it can intervene at a critical time in the disease to prevent it from progressing to a more dangerous stage, especially for high-risk patients,” said Dr Doron Sagman, vice -President. president of R&D and medical affairs at Eli Lilly Canada, told CBC News.

This photo provided by Eli Lilly shows the bamlanivimab antibody. On Monday, November 9, 2020, the United States Food and Drug Administration authorized the emergency use of bamlanivimab, the first cocktail of antibodies to help the immune system fight COVID-19. The drug is intended for people 12 years of age and older with mild or moderate cases of COVID-19 that do not require hospitalization. (Eli Lilly Co.)

“We hope it will make a significant contribution… as a bridge to vaccines,” said Sagman, 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 this is going to be very important. ”

Although clinical data was submitted to US and Canadian regulators for approval around the same time in early October, Health Canada said it was not yet ready to approve the drug and its process review was continuing.

“Health Canada is committed to reviewing COVID-19 drugs and vaccines on an expedited basis. However, our top priority is to provide Canadians with access to safe, high-quality and effective medicines and vaccines, ”said a spokesperson for the ministry.

“Although Health Canada has received some requests, not all of the data necessary to support a vaccine or treatment approval has yet been received. The decision on vaccine and treatment approval will be made based on the evidence submitted by the sponsors. ”

Sagman said Eli Lilly provided data on the drug to Health Canada using the agency’s new continuous review process, which allows companies to submit clinical trial results as soon as they become available. This process allows drug manufacturers to reduce the long delays they normally face when bringing a new product to market.

“We have had active discussions with Health Canada regarding this regulatory process,” Sagman said, adding that distribution of the drug is on hold here until Health Canada makes its decision.

“We are working in partnership with governments around the world to ensure a fair and transparent distribution of a limited supply to those who need it. It will be difficult to meet the needs of the entire world population, but we will do what we can. “

In this May 2020 photo provided by Eli Lilly, researchers are preparing cells to produce possible COVID-19 antibodies to test in an Indianapolis lab. (David Morrison / AP Photo)

The US government struck a $ 375 million deal with Eil Lilly this summer to provide some 300,000 vials of antibody treatment. The company will begin fulfilling these orders now that the FDA has given it the green light. The US approval of treatment is a welcome development for a country that experiences a record number of COVID-19 cases on a daily basis.

Canada has yet to negotiate a purchase agreement like that, said Sagman, but “there will be opportunities for the government” to enter into a similar bulk purchase agreement if and when Health Canada approves the agreement. drug.

A spokesperson for the company said it plans to deliver 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 cocktail of antibodies from another company, Regeneron, to US President Donald Trump when he contracted the virus in October. At the time, monocolonal therapy was considered experimental and was not allowed in most patients.

Trump touted the drug regime as a “cure”. It’s not – but some scientists have said the treatment could dramatically reduce stress on healthcare systems by reducing the number of hospitalizations.

The drug reduced the rate of hospitalizations and emergency room visits in patients at high risk for disease progression, Eli Lilly said when publishing her results in the peer-reviewed New England Journal of Medicine.

Among patients at high risk of disease progression, hospitalizations and emergency room visits occurred in only 3% of cases treated with bamlanivimab on average, compared with 10% of patients treated with placebo, the FDA said. upon issuance of its Emergency Use Authorization (EUA) on Monday.

“What we’ve learned is that it’s important to intervene early to lower the viral load before it progresses to a more advanced inflammatory stage requiring in-hospital interventions,” said Sagman. “This should be administered as soon as possible after a COVID-19 test. ”

Authorization of treatment “provides healthcare professionals on the front lines of this pandemic with another potential tool in the treatment of COVID-19 patients,” said Dr Patrizia Cavazzoni, interim director of the Center for Drug Evaluation and Research at the FDA, in a statement.

The US regulator said the treatment, which is given by intravenous injection in a healthcare setting, should only be used on patients in the early stages of infection because treatment “may be associated with worse clinical outcomes. »For people already hospitalized. for complications related to COVID-19.

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