Updated at 12:26 pm EST
Pfizer (PFE) said Thursday that it's submitted a new application to the U.S. Food & Drug Administration seeking formal approval for the sale of its Covid oral treatment Paxlovid.
Pfizer said the New Drug Application (NDA) request would apply to patients who are at 'high risk' in terms of progressing to severe illness from Covid 19. That would essentially match the parameters of its current Emergency Use Authorization, which the FDA granted in December of last year.
The application follows a new $3.2 billion agreement with the U.S. government for 105 million doses of its Comirnaty Covid vaccine at around $30 per dose, up from the $19.50 price it originally negotiated with it partner, BioNtech (BNTX) , in late 2020.
Pfizer said last month that it expects record 2022 revenues of more than $100 billon, with gains paced by Comirnaty sales, which are expected to top $32 billion.
The group also repeated sales forecasts for Paxlovid, which are seen coming in at $22 billion, despite disappointing late-stage data from a trial involving 3,000 adults with 'household contacts' that were infected by Covid failed to meet its primary endpoint of reducing the overall risk of infection.
“As the Covid pandemic continues to evolve and be highly unpredictable, we must remain vigilant in protecting those who are at greatest risk of getting very sick from Covid, as they remain vulnerable to potential hospitalization or even death,” said CEO Albert Bourla.
"Data from our clinical development program, coupled with the more than 1.7 million patients around the world who have been prescribed our oral treatment to date, reinforce Paxlovid as an important treatment option for mild-to-moderate Covid-19 in patients at greater risk of progression to severe symptoms, regardless of vaccination status," he added. "We look forward to working with the FDA toward full regulatory approval for Paxlovid.”
Pfizer shares were marked 2.2% higher in early afternoon trading Thursday to change hands at $52.08 each, a move that would trim the stock's year-to-date decline to around 11.8%.
Late last year, Pfizer said it will sell around 10 million of its Paxlovid treatment, which won Emergency Use Approval (EUA) by the U.S. Food & Drug Administration on December 22, to the United States Department of Health and Human Services.
At $530 per tablet, the cost is around 25% cheaper than the $700 price agreed with Merck & Co. MRK in October to buy 1.7 million doses its 'molnupiravir' treatment of "mild-to-moderate Covid in adults who are at risk for progressing to severe forms of disease, or hospitalization.