Xocova's emergency approval: "presumed" effective, obviously unnecessary
After the Upper House elections in July, I predicted that the government would maintain Covid's special legal status to justify giving emergency approval to domestically developed drugs and jabs based on their "presumed" effectiveness.
Well, four and a half months have passed, and Covid still hasn’t been downgraded to Category 5 along side the flu. And guess what happened last week.
Am I hot or what?
Japan's health ministry on Tuesday granted fast-track approval to Shionogi & Co.'s COVID-19 tablet Xocova, making it the country's first domestically produced oral medicine against the coronavirus.
The medicine for COVID-19 patients aged 12 or older with mild symptoms also became the first drug authorized under the new emergency approval scheme established in May.
The Pharmaceuticals and Medical Devices Agency, which conducted the preliminary review, acknowledged in a report that it had "obtained sufficient information to presume the drug is effective" from final phase clinical trial results submitted by Shionogi.
So what is the compelling data that enabled the PMDA to make this presumption?
Although the trials showed effectiveness in reducing coronavirus in the body, there were no substantial differences in alleviating a total of 12 symptoms such as headaches and nausea between those given the drug versus the placebo.
But an analysis of five symptoms characteristic of the Omicron strain -- runny nose, sore throat, cough, fever and fatigue -- in the final phase of the trials showed the drug shortened symptoms from eight days to seven days.
So even though Xocova didn't make a statistically significant difference overall, it still got emergency approval for clearing runny noses one day earlier. One day! They don't make emergencies like they used to.
The question of whether Xocova can prevent progression to severe disease is basically irrelevant because there are 36 medications that can't be used in combination with it. In other words, if you're taking medication for an underlying medical condition that puts you at higher risk of severe Covid, you probably can't take Xocova.
Entertainingly, a representative from the Ministry of Health, Labour and Welfare justified the emergency approval by saying "There's no existing medication that can be prescribed to patients who aren't at risk of severe Covid." Brilliant logic there: Xocova must be approved because there is no anti-Covid medication for people who don't need anti-Covid medication.
Now Xocova has been given emergency approval in Japan, Shionogi plans to apply for approval overseas too. It hopes to annually distribute enough doses for 10 million people to 117 countries.
In Japan, Covid's special status means Taro Taxpayer will have to pick up the tab.
The Japanese government has agreed to purchase doses sufficient for one million people once the use of the drug, the third oral treatment in the country, is greenlit.
Japan still hasn't used about 80% of the Covid medications the government previously procured, so the public aren’t exactly crying out for more crappy Covid drugs. But Covid’s special status means drugmakers don’t have to worry about market forces. That said, I suppose compared with the 150 million doses of almost completely unused Novavax jabs the government procured, Japanese taxpayers are getting off lightly this time.
Speaking of unnecessary recombinant protein-based vaccines, Shionogi has even more news for us.
Japanese pharmaceutical firm Shionogi & Co. said Thursday it has applied with the health ministry for approval of its novel coronavirus vaccine.
It has marked the first application of a COVID-19 vaccine developed in Japan. Only two days after the ministry granted emergency approval for its coronavirus oral drug Xocova, the first for a domestic drugmaker, Shionogi is now seeking authorization to manufacture and sell the recombinant protein-based vaccine.
Why use the same platform as Novavax's unpopular shot?
If approved, it may become an option for those who previously could not receive coronavirus vaccine shots due to allergies or other issues.
"Other issues", huh? Sweden recently recommended people under 30 to not use Novavax due to increased risk of myopericarditis, so recombinant protein-based jabs seem to have the same issues as mRNA ones.
Anyway, how many fewer days of runny noses can we expect with Shionogi's injections?
According to Shionogi, the new vaccine's clinical trial for booster shot administration showed that the level of neutralizing antibodies, which help to block virus infection, in patients was around the same as those who have received Pfizer vaccines.
In its clinical trial for their first shots, the neutralizing antibody titer was seen to be statistically much greater than those inoculated with AstraZeneca Plc. vaccine, Shionogi said.
The answer to my question is apparently "Who knows? Who cares? Antibodies, Banzai!" In Japan’s Brave New World of emergency approval, any data will do.
I suppose I should end this post by congratulating Shionogi for being the first Japanese pharma company to fully get on board Japan’s Covid gravy train. And as long as Covid keeps its special status, the train will keep on rolling.