HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
To date, only Japan and the U.S. have approved use of the drug, with Japan approval coming within just four days from Gilead submitting the application.
Japan’s Ministry of Health, Labour and Welfare (MHLW) approved remdesivir to treat COVID-19 using an exceptional approval pathway. An MHLW source said the approval was granted using a “special process under the pharmaceutical law for overseas-developed products in times of emergency.” The MHLW took its cues from the FDA granting emergency use authorization for the drug on May 1.
Japan will start importing the drug from America in a few days, said the MHLW source.
The Japanese approval “is in recognition of the urgent need to treat critically ill patients in Japan,” said Merdad Parsey, Gilead’s chief medical officer. “It is a reflection of the exceptional circumstances of this pandemic.”
Japan has had almost 16,000 cases of COVID-19 and close to 800 deaths as of May 8, and Prime Minister Shinzo Abe extended a state of emergency until the end of May.
“There has so far been no coronavirus medicine available here, so it is a significant step for us to approve this drug,” an MHLW official said during a press briefing.
Gilead is in discussions with multiple companies for the manufacture of remdesivir, including generics makers. A source close to the matter told BioWorld that the drug is being produced in Europe and the U.S. but did not provide further details.
The source also did not specify whether Gilead was seeking approvals for the drug in other countries, but did say the company “continues to work with urgency to generate data on the safety and efficacy of remdesivir as a treatment for COVID-19, and [is in] in discussions with regulatory agencies to determine the most appropriate pathways to enable broader access to remdesivir, if the data is positive.”
The MHLW is also working to approve Avigan this month to treat mild cases of COVID-19. Avigan is a flu drug developed by a subsidiary of Fujifilm Holdings that can block the virus from reproducing in the body and which was already on track to be approved later this year. The health ministry has sped up the process but is awaiting the results of the ongoing phase III trials before giving its approval, said the MHLW source.
The clinical data used in the remdesivir approval were generated by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) through a global phase III trial as well as data from the company’s compassionate use program. Some of the patients enrolled in both the trial and the program were in Japan.
The FDA has not yet approved remdesivir. For the time being, the drug is only being distributed to treat hospitalized COVID-19 patients after trial data suggested the drug may speed up the recovery of patients with breathing issues requiring oxygen support.
Gilead describes remdesivir as a nucleotide analogue with broad-spectrum antiviral activity in vitro and in vivo. In animal models, the drug has shown itself useful against a range of pathogens like Ebola, MERS and SARS. The drug is undergoing several phase III trials.
The ministry source was not aware of any other drugs in development in Japan but said the ministry would evaluate other applications on a case-by-case basis.
In a study done by the U.S. NIAID that included 800 patients, remdesivir was shown to have cut hospital stays from 15 days to 11 in about half of patients and lowered mortality rate from 11.6% to 8% compared to the placebo group. The drug is administered intravenously.
Gilead Sciences is also conducting phase III trials for its JAK-1 inhibitor, filgotinib, to treat inflammatory bowel disease, specifically Crohn’s disease. The company has also filed an indication for rheumatoid arthritis in Japan.
Gilead stock (NASDAQ:GILD) reached a high of $78.31 on May 7, before closing at $77.61. Shares ended the week at $77.49.
Fujifilm advancing testing kits
Elsewhere in the country, Fujifilm Holdings announced that subsidiary Fujifilm Wako Pure Chemical Corp. has developed a COVID-19 testing reagent that could shorten the test result time, normally four to six hours, to 75 minutes. A company source said that a small, dedicated team started development on the MTAS (Micro Total Analysis System)-Wako- COVID-19 kit in February 2020, which started life as the SARS-CoV-2 R T- q PCR detection kit.
While both kits use the PCR reagent, the SARS-CoV-2 R T- q PCR detection kit can only perform two of the now four test processes and therefore its test times cannot be compared to the new version.
The name was inspired by Fujifilm’s MTAS technique and the subsidiary’s name.
The Fujifilm source declined to give the number of the test kits produced. The next step for the company will be to apply for IVD diagnostics approval to sell the kits. However, the source said that the company could still sell the kits under a special government emergency policy.