Pfizer’s Covid-19 oral drug Paxlovid is going through a crisis.
Since the end of April, many foreign media reported that some patients taking Paxlovid turned negative and then returned to positive.
In response, on May 3, Pfizer CEO Eberle said in an interview with Bloomberg: “After taking a course of Paxlovid, if the symptoms of the new crown recur, the doctor should give the patient a second medication.”
The implication is to add treatment.
This recommendation was rejected by the FDA. John Farley, FDA’s director of drug evaluation and research, responded: “There is currently no data to support longer dosing, and it cannot be proven that two five-day courses can solve the problem of recovery.
On May 3, Pfizer’s first quarterly report for 2022 showed that Paxlovid’s first-quarter revenue was $1.47 billion, significantly lower than sales expectations.
FDA explicitly rebuts Pfizer
The rumors of Fuyang after Paxlovid was discontinued appeared as early as two weeks ago.
Foreign media reported that some patients improved after taking Paxlovid for a five-day course of treatment, and the antigen test was also negative. However, a few days later, the symptoms of the new crown returned, and the antigen test was positive again.
In the form of a preprint paper, researchers at the Boston Veterans Health System describe a case of re-positive: a 71-year-old man who contracted COVID-19 and recovered quickly after taking Paxlovid. However, he returned positive 9 days after his first positive test, and his virus levels surged.
The emergence of Fuyang cases made the FDA re-examine the clinical trial of Paxlovid.
In fact, in the emergency use authorization document for Paxlovid disclosed by the FDA, it does document a small number of cases of virus rebound after taking the drug, mainly 10 to 14 days after taking the drug. , Pfizer did not disclose the specific incidence of Fuyang.
Pfizer explained this: The clinical trial set up a placebo group and a drug group, and a small number of patients had a higher viral load on the 10th to 14th day of taking the drug than on the 5th day, and two patients. This phenomenon occurred in all groups, so the virus rebound was independent of the drug. Pfizer CEO Aberle therefore said: Just keep taking the medicine.
This statement was refuted by the FDA. On May 4th, the FDA specially updated the introduction interface about Paxlovid, adding a paragraph about Fuyang.
The FDA clearly states that there is no evidence that prolonged treatment and repeated treatment sessions are beneficial to patients. But the FDA has nothing to do, but requires patients with Fuyang to seek medical attention and wear masks.
COVID-19 drug sales fall short of expectations
As the CEO of “Universe No. 1 Pharmaceutical Factory”, Abel directly suggested “adding a course of treatment” to the media, which may be related to the poor sales of Pfizer’s new crown drug.
On May 3, Pfizer’s 2022 first quarter report showed that Paxlovid’s revenue in the first quarter was US$1.47 billion. The outside world believes that this figure is much lower than sales expectations. After all, Pfizer’s estimated sales of Paxlovid in 2022 is $22 billion. It has been three months and one-tenth of the task has not been completed.
In contrast, Merck’s new crown drug molnupiravir, which is considered to be ineffective, had sales of $3.2 billion in the first quarter of this year. Merck & Co. expects the drug’s sales this year to be between US$5 billion and US$6 billion, and it has completed half a year’s KPIs in one quarter.
Pfizer’s Paxlovid was launched slightly later than Merck’s special drug, but has a wider sales coverage than Merck’s. In January of this year, Paxlovid was launched in the EU, while Merck’s special drug has only entered the UK market and is still awaiting EU approval.
In February this year, Paxlovid received conditional approval from the China Food and Drug Administration, and has been put into use in many provinces since March. The official price of the drug has never been disclosed, and Hangzhou Jingshi News once reported that it was 2,300 yuan per box.
Paxlovid’s sales fell short of expectations, and Pfizer was also actively trying to find a way, but the trial data did not help. On April 29, Pfizer announced that Paxlovid had no statistically significant effect in preventing new coronavirus infection. This means that the oral drug does not prevent Covid-19 infection.
Despite poor sales, Pfizer’s Paxlovid remains the hottest coronavirus drug in the world today. On April 21, the World Health Organization said: Paxlovid is the most effective of the existing treatments for COVID-19.
It is worth noting that Pfizer has not been calm recently, and there have been many changes in personnel. At the end of April, Pfizer’s 64-year-old head of vaccine development, Kathrin Jansen, decided to retire. Kathrin is the direct promoter of Pfizer’s mRNA vaccine.
China is also developing oral drugs for COVID-19, with more than 10 currently under development, and Real Bio, Junshi Bio and other drugs have entered Phase III clinical trials .