Patients given the medicine in Shenzhen, China, turned negative in a median of four days
Kenya government is to import a drug initially developed for flu in Japan that has been found to be effective in treating Coronavirus.
The Ministry of Health is expected to issue a statement on the application and availability of the drug without bureaucratic delay. Kenya are understandably anxious to know when the drug will be available in Kenya regardless of its efficacy.
In United States three Massachusetts hospitals have received approval to launch the first US clinical trial of a Japanese flu drug that could be used to treat COVID-19, according to a doctor involved in the effort.
The trial — which will take place at Massachusetts General Hospital, Brigham and Women’s Hospital, and UMass Memorial Medical Center in Worcester — was approved by the federal Food and Drug Administration Tuesday. The small, randomized trial of the antiviral drug favipiravir will look to study its effectiveness as a treatment for patients infected with the coronavirus, according to doctors involved in the study.
The Japanese government has touted the drug, known by the brand name Avigan, as a possible treatment for COVID-19 Medical authorities in China have called the drug “clearly effective” in treating coronavirus patients after conducting two clinical trials.
The trial is the latest development in the global race to find effective drugs to treat the potentially deadly illness. It is one of several efforts underway here in Boston and around the world among biopharmaceutical companies and hospitals seeking to deliver new weapons to health care providers battling the virus sweeping the globe.
One key focus of that supercharged research effort has involved looking at existing antiviral medicines to see if they prove effective against the coronavirus. The task is all the more urgent given most experts say a vaccine is at least a year away from FDA approval.
The initial US trial, as planned by the Massachusetts researchers, would involve roughly 50 or 60 patients across the three sites. One group would receive the drug along with the normal standard of care, while a second control group would receive only the normal care COVID-19 patients currently receive, according to officials involved in the trial. Further details about the protocol were not immediately available.
Dr. Keith T. Flaherty, who is leading a team of experts at MGH reviewing all the possible coronavirus-related clinical trials to see if the hospital should participate, said his group has so far deliberated over 30 possible trials since launching.
“We have to prioritize, and this absolutely rose to the top,” he said of the favipiravir trial, calling it one of the highest-priority studies the renowned teaching hospital is undertaking.
While the initial trial is relatively small, Flaherty said the hope is the hospitals could expand it if the drug shows promise.
The drug was produced by a pharmaceutical subsidiary of Japan-based Fujifilm more than a decade ago as a treatment for new and reemerging strains of influenza. The company has not yet confirmed the details of the US trial.
Some virologists and regulators have raised concerns about using it as a coronavirus treatment without further testing, though the Trump administration is reportedly pushing the FDA to approve it as an emergency treatment for the virus, according to Politico.
Doctors involved in the planned Massachusetts trial note that the drug has been used widely in humans, so the side effects are relatively well known. The potential benefits for a COVID-19 patient ill enough to be admitted to the hospital far outweigh the potential risks of side effects, the doctors said.
But they said it is important to conduct proper randomized trials on this and other potential treatments so researchers can gather evidence on which drugs actually improve patient outcomes.
In China, Zhang Xinmin, an official at China’s science and technology ministry, said favipiravir, developed by a subsidiary of Fujifilm, had produced encouraging outcomes in clinical trials in Wuhan and Shenzhen involving 340 patients.
“It has a high degree of safety and is clearly effective in treatment,” Zhang told reporters on Tuesday.
Patients who were given the medicine in Shenzhen turned negative for the virus after a median of four days after becoming positive, compared with a median of 11 days for those who were not treated with the drug, public broadcaster NHK said.
In addition, X-rays confirmed improvements in lung condition in about 91% of the patients who were treated with favipiravir, compared to 62% or those without the drug.
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Fujifilm Toyama Chemical, which developed the drug – also known as Avigan – in 2014, has declined to comment on the claims.
Shares in the firm surged on Wednesday following Zhang’s comments, closing the morning up 14.7% at 5,207 yen, having briefly hit their daily limit high of 5,238 yen.
Doctors in Japan are using the same drug in clinical studies on coronavirus patients with mild to moderate symptoms, hoping it will prevent the virus from multiplying in patients.
But a Japanese health ministry source suggested the drug was not as effective in people with more severe symptoms. “We’ve given Avigan to 70 to 80 people, but it doesn’t seem to work that well when the virus has already multiplied,” the source told the Mainichi Shimbun.
The same limitations had been identified in studies involving coronavirus patients using a combination of the HIV antiretrovirals lopinavir and ritonavir, the source added.
In 2016, the Japanese government supplied favipiravir as an emergency aid to counter the Ebola virus outbreak in Guinea.
Favipiravir would need government approval for full-scale use on Covid-19 patients, since it was originally intended to treat flu.
A health official told the Mainichi the drug could be approved as early as May. “But if the results of clinical research are delayed, approval could also be delayed.”
Shares in Fujifilm Toyama Chemical, which developed favipiravir, surged after praise by Chinese official following clinical trials