Paxlovid Approved in the U.S.

Highlights

Pfizer has launched Paxlovid (nirmatrelvir + ritonavir), a new drug indicated to treat mild-to-moderate COVID-19 infection (confirmed by SARS-CoV-2 coronavirus testing) in adults and children (12 years and older, body weight 40 kg and above) at high risk for progression to severe disease requiring hospitalization or may be fatal.

Paxlovid is the first oral antiviral medication for home use with reliably proven therapeutic efficacy.

The introduction of Paxlovid is especially relevant in the current context of the next wave of coronavirus, now represented by the Omicron strain (B.1.1.529), which is spreading extremely rapidly around the planet.

 

Details

The U.S. Food and Drug Administration (FDA) has approved Paxlovid under its Emergency Use Authorization (EUA) program. Pfizer intends to seek full regulatory approval in 2022.

The European Medicines Agency (EMA) continues to review Paxlovid’s application. However, the pan-European regulator has recommended treatment with Paxlovid for eligible patients if national regulators decide to do so, without waiting for the EMA’s final verdict.

• Paxlovid is not indicated for the treatment of patients requiring hospitalization due to severe or critical COVID-19.
• Paxlovid is not used for pre-exposure or post-exposure prophylaxis of COVID-19.
• Paxlovid should be administered as soon as possible after diagnosis of COVID-19 and within 5 days of disease symptoms onset.
• Paxlovid is administered orally every 12 hours (two 150-mg tablets of nirmatrelvir and one 100-mg tablet of ritonavir) for 5 days and no longer than that.

In a clinical trial of Paxlovid, the drug for COVID-19 reduced the risk of hospitalization or death by 89% and 88% when given within 3 and 5 days of COVID-19 symptoms manifestation, respectively. Among elderly patients, this risk reduction was even better, at 94%.

According to Pfizer, Paxlovid maintains its highest antiviral efficacy against the Omicron variant.

Pfizer is ready to offer 180,000 therapeutic courses of Paxlovid in the current year of 2021. The U.S. pharmaceutical giant intends to produce 120 million courses of Paxlovid in the next 2022.

The U.S. government has signed a contract for the purchase of 10 million courses of Paxlovid — treatment of one patient costs 530 dollars.

Meanwhile, Merck & Co. has launched molnupiravir, the same oral drug for COVID-19 as Paxlovid but with a different mechanism of action. The claimed therapeutic efficacy of molnupiravir was significantly lower. In addition, it is not suitable for all patients. As a result, according to industry projections, if Pfizer earns $17 billion on Paxlovid sales in 2022, molnupiravir will bring Merck & Co. $2.5 billion.

Under an agreement signed with the Medicines Patent Pool (MMP) of UNITAID, low-cost generic copies of Paxlovid will appear in 95 lower-middle-income countries in 2022.

• In states that officially lack the availability of low-cost clones of Paxlovid, its price will be based on the income level of each particular country. In high and upper-middle income countries, the price of Paxlovid will be billed higher than in low-income countries. Obviously, many people will want to buy Paxlovid, which will inevitably lead to the formation of a black market: speculators and intermediaries will establish supply channels for inexpensive Paxlovid from India, Egypt, and other countries where large-scale generic production will be established.

Read all the information about the clinical efficacy of Paxlovid and how it works in an extensive BioPharma Media’s article — Paxlovid: New Cure for Coronavirus.

 

Extras

Paxlovid (nirmatrelvir + ritonavir). Prescribing information. U.S. [PDF]