Pfizer Inc. (NYSE: PFE) grabbed the market’s attention yesterday after the US FDA (Food and Drug Administration) approved licensed pharmacists to recommend (with certain restrictions) the intake of Paxlovid – an antiviral drug (nirmatrelvir/ritonavir)-by patients infected by the coronavirus. The brand Paxlovid is owned by the major pharmaceutical Pfizer. The stock of Pfizer closed at $53.42, up 1.27% or $0.67 from its prior close.
The FDA has amended the Emergency Use Authorization (EUA) for the pill such that patients who are at increased risk of acute COVID-19 will be able to gain access to the medication. The restrictions were laid out to make sure of relevant examination of the patient and the suggestion of Paxlovid.
Notably, at the end of June, Pfizer tabled a New Drug Application (NDA) to the FDA for authorization of Paxlovid pills for both unvaccinated and vaccinated patients who face an increased risk of acute illness due to coronavirus infection.
As per the emergency use authorization, the pill can be prescribed to COVID-19-positive adults and pediatric patients—aged at least 12 years and weighing a minimum of 40 kg—with high chances of progressing to acute illness.
The FDA has now stated that COVID-19 patients should initially look at the option of getting treated by their regular healthcare provider or looking for a local Test-to-Treat venue. This will pave the way for state-licensed pharmacists to suggest Paxlovid with necessary restrictions. Additionally, as per the FDA’s guidelines, community pharmacies that are not part of a Test-to-Treat venue can also choose the manner in which they will offer the aforementioned service to COVID-19 patients.
For evaluation of eligibility to get the pill from licensed pharmacists, coronavirus-infected patients should submit health-related documents that are less than a year old, in addition to the list of all drugs (even over-the-counter) being taken regularly.
In accordance with the restrictions imposed along with the approval, the pharmacist is required to send patients for clinical examination by a physician, a nurse enrolled for advanced practice, or an assistant of a physician, in cases where adequate data is not available.
Regarding the changes, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, pointed out that “as administration of Paxlovid should be done before five days from the first appearance of symptoms, allowing licensed pharmacists to recommend the pill might increase access to therapy in a timely manner for those patients who are eligible to claim this pill for the treatment of COVID-19.”
As per the EUA, patients who test positive for a home-based rapid antigen diagnostic test are also eligible for Paxlovid. Currently, over 65 countries have endorsed the pill for emergency (or conditional) use to treat coronavirus-infected patients with high chances of progressing to acute illness.
The news of the FDA’s relaxation on the Paxlovid drug is expected to keep the stock range-bound with a slight bullish bias in the short term.
The historical price chart indicates that the stock of Pfizer has clearly broken the ascending triangle pattern. The stock is also trading above its 50-day moving average, while the Chaikin money flow indicator is showing a positive reading. Therefore, we anticipate the stock to remain in an uptrend in the short term.
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