Health Canada is still reviewing data from manufacturer Merck on its anti-viral drug against COVID-19 which was cleared Thursday in the UK.
The federal regulator said Thursday it was continuing to receive data “as new information becomes available” from pharmaceutical company Merck on the drug molnupiravir, considered the first pill to successfully treat COVID-19. Health Canada does not offer a timeline for completing the review process.
Molnupiravir was granted conditional clearance for use in Britain on Thursday, but it was not clear when the pill would be available there.
Merck has been providing data to Health Canada on an ongoing basis since August, when the product was still in clinical trials. The federal regulator recalls that its review must determine whether the benefits of the drug outweigh the risks. Health Canada must also ensure that this drug meets “strict requirements for safety, efficacy and quality”.
Merck announced preliminary results in September showing its drug halved hospitalizations and deaths in patients with early symptoms of COVID-19. However, the results have not yet been peer reviewed or published in a scientific journal.
The drug company also did not disclose details of the side effects of molnupiravir, except to say that the rates were similar between people who received the drug and those who received a placebo.
Against the influenza virus
Molnupiravir was first studied as a potential treatment for influenza, with funding from the US government. Last year, researchers at Emory University in Atlanta decided to use the drug as a potential treatment for COVID-19. They then licensed the drug to pharmaceutical Ridgeback and its partner Merck.
The drug targets an enzyme that the coronavirus uses to reproduce itself, inserting errors into its genetic code, which slow down its ability to spread and take control of human cells. This genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumors.
The UK Medicines and Health Products Regulatory Agency said molnupiravir’s ability to interact with DNA and induce mutations has been “extensively” studied and has not been shown to present. a risk for humans.
Dr. Sumon Chakrabarti, an infectious disease expert in Mississauga, Ont., Said molnupiravir is intriguing because the errors it inserts into the genetic code are not recognized as such by SARS-CoV-2. “So that leads to massive mutations and the virus dies,” he said. “It’s more ‘cool’, actually. ”
Merck Canada said Thursday that a supply agreement was not yet in place, but discussions with the Canadian government were underway.
Molnupiravir is also awaiting review by regulatory agencies in the United States, the European Union and elsewhere in the world. In the United States, the FDA announced last month that it would convene a panel of independent experts to review the safety and effectiveness of the pill in late November.
Merck and its partner Ridgeback Biotherapeutic have asked to authorize the drug for adults with early cases of COVID-19 who are at risk of serious illness or hospitalization.
The pill, which the patient takes at home, has been approved in Britain for adults 18 years and older who have tested positive for COVID-19 and who have at least one risk factor for developing serious illness , such as obesity or heart disease. Patients with mild to moderate symptoms would take four tablets of the drug twice a day for five days.
According to Professor Chakrabarti, who has not seen the data on the clinical studies, the drug should however be taken at the onset of the infection. “The symptom reduction rate is not spectacular […], but anything that can reduce hospitalizations is welcome. ”
With information from the Associated Press