Fujifilm to Seek Approval for Covid Drug After Trial Results
(Bloomberg) -- Fujifilm Holdings Corp. said it would seek regulatory approval in Japan to market an antiviral drug as a treatment for Covid-19, after a trial showed that it helped patients with mild cases test negative for coronavirus faster.
The company plans to apply for approval to expand usage of the drug Avigan as early as October in Japan, it said in a statement Wednesday. The drug, also known by its generic name favipiravir, is currently approved for use in Japan to treat novel influenza. Fujifilm’s stock rose as much as 5% in Tokyo trading after the announcement.
In a trial of 156 patients, those who took the drug tested negative for coronavirus in a median 11.9 days, compared to 14.7 days for the placebo group, said the statement. The clinical trial was randomized and single-blinded, meaning doctors knew which patients received which treatment. No safety concerns emerged in the trial.
While drugmakers around the world are racing to find a vaccine to bring the coronavirus under control, doctors and firms are also scouring labs for existing treatments that can help people survive the pathogen. Among other drugs to have shown some effect against Covid-19 in stringent clinical tests are Gilead Sciences Inc.’s antiviral remdesivir and steroids such as the 60-year-old dexamethasone.
Avigan has been promoted heavily by the Japanese government and donated to over 80 countries in recent months, even before clinical trials were completed. Fujifilm said it has been working to increase production of Avigan to meet supply demands from Japan and other countries. The drug has the potential to cause birth defects because of its mechanism of stopping RNA replication.
A tweaked version of the drug has been approved for use in Russia. Fujifilm also signed a licensing pact with India’s Dr. Reddy’s Laboratories Ltd. in July to manufacture and develop the drug outside Japan, excluding China and Russia.
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