- PF-07321332 & Ritonavir (Paxlovid): Pfizer Gets CDSCO Panel Nod To Study For COVID Treatment. The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. it is India’s national regulatory body for cosmetics, pharmaceuticals, and medical devices.
- Earlier this week, Pfizer announced an agreement with the US government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate of PF-07321332 and ritonavir (Paxlovid), subjected to regulatory authorization from the FDA, according to a recent press release.
- Under the agreement, the government would acquire 10 million treatment courses to be delivered by Pfizer beginning later this year and concluding in 2022.
- Pfizer will receive $5.29 billion from the government upon regulatory authorization, and the price being paid by the government is reflective of the high committed volume of treatment courses being purchased through 2022.
- Pfizer has also entered into advance purchase agreements with several other countries and has initiated bilateral outreach to approximately 100 countries.
- If approved or authorized, PF-07321332 would be the first oral antiviral 3CL protease inhibitor specifically designed to combat SARS-CoV-2. It would be administered at a dose of 300 mg (two 150 mg tablets) with one 100 mg tablet of ritonavir, given twice a day for 5 days.
- Pfizer to allow Generic Versions of its Covid-19 Pill (Paxlovid) in 95 Countries
In a significant development, pharmaceutical major Pfizer has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct a trial of oral antiviral clinical candidate
Paxlovid (PF-07321332)/Ritonavir in the treatment of COVID 19 the final study data from the clinical Phase I study (FIH Study) to the CDSCO for review.
Further, the expert panel instructed that the firm should submit the completed nonclinical toxicological study data.
This came after the drug-maker Pfizer presented the proposed amended study protocol no. C4671002, Amendment 3 dated 03Aug2021 with justification in line with the earlier recommendation.
Ritonavir is an antiretroviral protease inhibitor that is widely used in combination with other protease inhibitors in the therapy and prevention of human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS).
Protease inhibitors bind to a viral enzyme (called a protease), preventing the virus from replicating in the cell. Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both alone and in combination with other antivirals.
Pfizer stated in a press release that already marketed viral protease inhibitors are not often linked with toxicity, and as a result, this class of medicines could potentially deliver well-tolerated COVID-19 therapy.
a SARS-CoV2-3CL protease inhibitor has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use
to address future coronavirus threats.
Furthermore, it added, “The Phase 1 trial is a randomized, double-blind, sponsoropen, placebo-controlled, single- and multiple-dose escalation study in healthy adults evaluating the safety, tolerability, and pharmacokinetics of PF-07321332.”
Earlier, at the 178th SEC meeting to examine COVID-19 related proposals under the accelerated approval process, held on 26.08.2021 & 27.08.2021, the firm presented the proposal for Phase II/III clinical study protocol no. C4671002,
Amendment 2, dated July 19, 2021, before the Subject Expert Committee (SEC) of after receiving complete pre-clinical toxicity data and clinical Phase I data with proposed IP.
Accordingly, at the 183rd SEC meeting held on September 16, 2021 at CDSCO, the firm presented the proposed amended-study protocol no. C4671002, Amendment 3, dated August 3, 2021, with justification.
After detailed deliberation, the Committee recommended the grant of permission to conduct the proposed clinical trial with the following conditions:
1) Up to 100 subjects from India should be recruited for the study.
2) The firm should submit the final study data from the clinical Phase I study (FIH
Study) to the CDSCO for review.
3) The firm must submit the results of the non-clinical toxicological study.