- YOMIURI EDITORIAL
- Emergency approval
How will new COVID-19 drug reach patients told to avoid visiting clinics?
12:29 JST, November 25, 2022
Xocova, a drug developed by Shionogi & Co. for the treatment of novel coronavirus infections, has been granted emergency approval. It is the first Japan-made oral medicine that can be used for people with mild COVID-19 symptoms, and it is essential that the new drug be utilized appropriately.
The emergency approval system is a mechanism whereby approval is granted earlier than normal if there are no safety issues and if the drug is presumed to be effective. This is the first application of the system. If the efficacy of the drug cannot be confirmed within a certain time frame, the approval is revoked. In the case of Xocova, the time limit has been set at one year.
In June and July, emergency approval of Xocova was discussed based on interim results of clinical tests, but it was decided not to green-light the drug for fast-track approval on the grounds that its effectiveness could not be presumed, and the discussions continued.
Subsequent clinical tests showed that Xocova was effective in shortening by one day the time before symptoms common to the omicron variant of the virus, such as sore throat and fever, disappeared, and the emergency approval was granted. The fact that increased COVID-19 treatment options have become available in time for the eighth wave of the pandemic is a source of reassurance.
While the two overseas oral drugs used in Japan are limited to elderly patients, who are at high risk of developing severe symptoms, Xocova has the advantage of being suitable for younger people with mild or moderate symptoms.
However, there are 36 drugs that cannot be used in combination with Xocova. Also, pregnant women cannot use it. Moreover, there may be differing opinions about the value of shortening symptoms by “one day.”
At this point, it has not even been confirmed whether the drug is effective in preventing serious symptoms. Excessive expectations for Xocova must be guarded against so that the drug will not be used inappropriately.
Another issue is how to get the drug to patients. Currently, the government has instructed hospitals and clinics who treat outpatients with fevers to give priority to the elderly and those with underlying illnesses. All others are required in principle to stay home during their illness and not visit clinics at all.
However, Xocova is not effective unless it is taken within three days of the onset of symptoms, and written consent of the patient is required to prescribe it. How can patients with mild symptoms who are eligible for the drug obtain it while staying at home?
Unless an environment is created for COVID-19 patients to obtain Xocova more readily, the significance of the emergency approval will be undermined. It is hoped that a system will be put in place as soon as possible so that patients can receive medical treatment and prescriptions with peace of mind.
Serious side effects of new drugs may be identified after their release. It is important for the government and pharmaceutical companies to rigorously collect information and share it with the public.
The fast-track drug approval system will also be important in the event of future outbreaks of new infectious diseases. The fact that the approval was postponed twice for continued discussions has been criticized by some, who say that the decision-making criteria are unclear.
In order to make the most of the system, the government needs to examine the issues that have been identified and work on improvements.
(From The Yomiuri Shimbun, Nov. 25, 2022)
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