Pfizer signs agreement with UK govt to supply Paxlovid to combat COVID-19 – ET HealthWorld


New York : Pfizer Inc. inks an additional agreement with the United Kingdom (UK) Government to supply an additional 2.5 million treatment courses of its investigational candidate Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), subject to local authorization. This is in addition to the 250,000 treatment courses previously contracted by the UK Government, pending authorization and recommendation for use, bringing the full amount of treatment courses to 2.75 million.

“Final data from our phase 2/3 trial in high-risk participants confirmed the overwhelming efficacy of Paxlovidin reducing the risk of hospitalization by nearly 90% compared to placebo when treated within both three and five days of symptom onset and no deaths. We are pleased that the UK government recognizes the importance of this potential treatment option,” said Albert Bourla, Chairman and CEO, Pfizer.

“As we continue to combat the virus, we are in discussions with governments around the world to help ensure we get this potential treatment to patients as quickly as possible, subject to authorization or approval,” Bourla mentioned.

In anticipation of the potential for regulatory authorization or approval, Pfizer initiated manufacturing of Paxlovid earlier this year and expects to produce up to 80 million courses of treatment by the end of 2022, with 30 million treatment courses available in the first half of the year.

Pfizer is committed to working toward equitable access to Paxlovid for all people, aiming to deliver well-tolerated and effective antiviral therapeutics as soon as possible and at an affordable price. If authorized or approved, during the pandemic, Pfizer will offer our oral antiviral therapy through a tiered pricing approach based on the income level of each country to promote equity of access across the globe. High and upper-middle income countries will pay more than lower income countries.

Pfizer continues to invest up to approximately $1 billion to support the manufacturing and distribution of Paxlovid, including exploring potential contract manufacturing options. It has entered into agreements with multiple countries and has initiated bilateral outreach to approximately 100 countries around the world. Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral antiviral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53 percent of the world’s population.

Paxlovid is an investigational SARS-CoV-2 protease inhibitor antiviral therapy. It was developed to be administered orally so that, if authorized or approved, it can be prescribed at the first sign of infection or, pending clinical success of the rest of the EPIC development programme and subject to regulatory authorization, at first awareness of an exposure – potentially helping patients avoid severe illness (which can lead to hospitalization and death) or avoid disease development following contact with a household member who contracts Covid-19. Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the SARS-CoV-2 3CL (or main) protease, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

Current variants of concern can be resistant to treatments that are focused on the spike protein expressed on the surface of the SARS-CoV-2 virus, due to the mutations in this region. Paxlovid, however, works intracellularly on the protease of the SARS-CoV-2 virus by inhibiting viral replication. Nirmatrelvir has shown consistent in vitro antiviral activity against the previously identified variants of concerns (i.e., alpha, beta, delta, gamma, lambda, and mu). In addition, nirmatrelvir potently inhibited the main protease associated with Omicron in an in vitro biochemical assay. This indicates nirmatrelvir’s potential to maintain robust antiviral activity against Omicron. Additional in vitro antiviral studies with this variant are underway.

If authorized or approved, Paxlovid will be administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One carton contains five blister packs of Paxlovid, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

The EPIC (Evaluation of?Protease?Inhibition for?Covid-19) phase 2/3 development program for Paxlovidconsists of three clinical trials spanning a broad spectrum of patients, including adults who have been exposed to the virus through household contacts, as well as adults at both standard risk and high risk of progressing to severe illness.

In July 2021, Pfizer initiated the first of these trials, known as EPIC-HR, a randomized, double-blind study of non-hospitalized adults with Covid-19, who are at high risk of progressing to severe illness. At the recommendation of an independent Data Monitoring Committee and in consultation with the US FDA, Pfizer ceased further enrollment into the study in early November 2021 due to the overwhelming efficacy demonstrated in these results. Findings from the EPIC-HR interim analysis have been submitted to a peer-reviewed journal for publication.

In August 2021, Pfizer began the phase 2/3 EPIC-SR (Evaluation of?Protease?Inhibition for?Covid-19 in?Standard-Risk Patients), to evaluate efficacy and safety in adults with a confirmed diagnosis of SARS-CoV-2 infection who are at standard risk (i.e., low risk of hospitalization or death). EPIC-SR includes a cohort of vaccinated adults who have an acute breakthrough symptomatic COVID-19 infection and who have risk factors for severe illness. Interim data from this study have been reported. In September, Pfizer initiated the Phase 2/3 EPIC-PEP (Evaluation of?Protease?Inhibition for?Covid-19 in?Post-Exposure?Prophylaxis) to evaluate efficacy and safety in adults exposed to SARS-CoV-2 by a household member and these trials are ongoing.





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