- If approved or authorized, PAXLOVID™ (PF-07321332; ritonavir) would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2
- EUA submission includes clinical data from an interim analysis of the Phase 2/3 EPIC-HR study, which demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death compared to placebo in non-hospitalized high-risk adults with COVID-19
- Rolling submissions have commenced in several countries including in the United Kingdom, Australia, New Zealand and South Korea, with planned submissions to other regulatory agencies around the world
PfizerInc. moment blazoned it’s seeking Exigency Use Authorization (EUA) of its investigational oral antiviral seeker, PAXLOVID ™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in cases at increased threat of hospitalizations or death. This submission to theU.S. Food and Drug Administration (FDA) includes clinical data from the Phase2/3 EPIC-HR ( Evaluation of Protease Inhibition for COVID-19 in High- Threat Cases) interim analysis. Rolling submission ofnon-clinical data for PAXLOVID was initiated with theU.S. FDA in October 2021.
Still, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease asset specifically designed to combat SARS-CoV-2 that could be specified as an at- home treatment to high- threat cases at the first sign of infection, If authorized or approved.
“ With further than 5 million deaths and innumerous lives impacted by this ruinous complaint encyclopedically, there’s an critical need for life- saving treatment options. The inviting efficacity achieved in our recent clinical study of PAXLOVID, and its implicit to help save lives and keep people out of the sanitarium if authorized, underscores the critical part that oral antiviral curatives could play in the battle against COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “ We’re moving as snappily as possible in our trouble to get this implicit treatment into the hands of cases, and we look forward to working with theU.S. FDA on its review of our operation, along with other nonsupervisory agencies around the world.”
Pfizer is seeking EUA for PAXLOVID grounded on positive results from the EPIC-HR interim analysis, which enrollednon-hospitalized grown-ups progressed 18 and aged with verified COVID-19 who are at increased threat of progressing to severe illness. The data demonstrated an 89 reduction in threat of COVID-19-related hospitalization or death from any cause in cases treated with PAXLOVID compared to placebo within three days of symptom onset, with no deaths in the treatment group. Analogous results were seen with within five days of symptom onset. Treatment-imperative adverse events were similar between PAXLOVID (19) and placebo (21), utmost of which were mild in intensity. At the recommendation of an independent Data Monitoring Committee, and in discussion with theU.S. FDA, Pfizer desisted farther registration into the study due to the inviting efficacity demonstrated. Rolling cessions have commenced in several countries including in the United Kingdom, Australia, New Zealand and South Korea, with planned cessions to other nonsupervisory agencies around the world to follow.
Pfizer has begun and will continue to invest up to roughly$ 1 billion of its own finances to support the manufacturing and distribution of this investigational treatment seeker. Also, Pfizer has inked a voluntary licensing agreement with the Medicines Patent Pool (MPP) to help expand access, pending nonsupervisory authorization or blessing, in 95 low-and middle- income countries that regard for roughly 53 of the world’s population.
About PAXLOVID (PF-07321332; ritonavir)
PAXLOVID is an investigational SARS-CoV-2 protease asset antiviral remedy. It was specifically designed to be administered orally so that it can be specified at the first sign of infection or at first mindfulness of an exposure – potentially helping cases avoid severe illness (which can lead to hospitalization and death), experience a dropped characteristic period, or avoid complaint development following contact. PF-07321332 is designed to block the exertion of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate.
PF-07321332 inhibits viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, PF-07321332 didn’t demonstrate substantiation of mutagenic DNA relations.
Still, PAXLOVID will be administered at a cure of 300 mg (two 150 mg tablets) of PF-07321332 with one 100 mg tablet of ritonavir, given doubly-diurnal for five days, If authorized or approved.
Our Commitment to Equitable Access
Pfizer has also begun and will continue to invest up to roughly$ 1 billion of its own finances to support the manufacturing and distribution of this investigational treatment seeker, including exploring implicit contract manufacturing options. It has entered into advance purchase agreements with several countries and has initiated bilateral outreach to roughly 100 countries around the world. Also, Pfizer has inked a voluntary license agreement with the Medicines Patent Pool (MPP) for PF-07321332; ritonavir to help expand access, pending nonsupervisory authorization or blessing, in 95 low-and middle- income countries that regard for roughly 53 of the world’s population.
About Pfizer Improvements That Change Cases’Lives
At Pfizer, we apply wisdom and our global coffers to bring curatives to people that extend and significantly ameliorate their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative drugs and vaccines. Every day, Pfizer associates work across developed and arising requests to advance heartiness, forestallment, treatments and cures that challenge the most stressed conditions of our time. Harmonious with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we unite with health care providers, governments and original communities to support and expand access to dependable, affordable health care around the world. For further than 170 times, we’ve worked to make a difference for all who calculate on us.
Source link; https://www.pfizer.com/
