TOKYO -- The Japanese government is considering fast-track approval for an oral medication being developed by Japanese pharmaceutical giant Shionogi & Co. for mild COVID-19 symptoms, paving the way for a rollout as early as this spring.
The medication is in the final phase of clinical trials, with a target test group of some 2,000 patients. But the government is considering making the drug available for practical use before the trial is completed via a conditional early approval system.
According to the government's scenario, prerequisites for fast-track approval include confirmation of the drug's efficacy in an interim analysis of results from several hundred clinical trial participants. The government is coordinating to purchase the drug.
Oral medication given at an early stage in infection to prevent patients from developing severe COVID-19 is considered a coronavirus countermeasure trump card. In Japan, Merck & Co. Inc.'s molnupiravir has already entered practical use, while a Pfizer Inc. drug is expected to be approved soon. However, as they are foreign-made, supplies are limited, and they are targeted at a narrow band of patients. This has sparked calls for the quick introduction of domestically produced COVID-19 medications.
In Japan, fast-track approval can be granted to imported drugs already in general use in the United States and other major countries, but this does not apply to domestic drugs. The government is planning to submit a bill to revise Japan's medical device and pharmaceuticals law to the current Diet session, to create a new emergency approval system for drugs even at the clinical trial phase if they are presumed to be effective and confirmed safe.
If the legislation is enacted, it will be possible to put Japanese-made drugs into practical use earlier than under the current system. However, the legislative process will not be finished in time to fast-track Shionogi & Co.'s new COVID-19 medication.
Conditional fast-track approval, meanwhile, is an existing system that allows a drug to be authorized even midway through clinical trials, if the drug is highly useful but faces final-phase clinical trial hurdles such as a target patient shortage. Quick approval is given on condition that a certain degree of safety and efficacy has been confirmed, and additional data is submitted after it is put into practical use, among other requirements.
While the system was introduced with an eye to applying it to medications for rare diseases and cancer, the Ministry of Health, Labor and Welfare believes it can also cover COVID-19 medications.
Shionogi & Co. launched final-phase clinical trials of its new COVID-19 drug at the end of September 2021. Data released by the company shows that in the first half of the trial with 69 subjects, the amount of coronavirus in the body decreased more quickly among patients given the candidate drug than those on a placebo. However, the health ministry is focusing on data from the latter half of the trial.
Provisional confirmation of the drug's efficacy is needed for conditional fast-track approval. The ministry is considering applying the system to domestic COVID-19 medications when interim analysis shows a "significant difference" between patients getting a candidate drug versus the control group, according to a senior ministry official.
Shionogi & Co. has already started commercial production of the COVID-19 drug. The firm has stated that it can produce doses for 1 million people by the end of March, and boost that to doses for 10 million people in fiscal 2022.
(Japanese original by Ai Yokota, Lifestyle and Medical News Department)