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FDA clears two oral drugs for COVID-19 – Medical Products Supply Chain Weekly Review – Food, Drugs, Healthcare, Life Sciences

United States: FDA clears two oral drugs for COVID-19 – Medical products supply chain review of the week

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Last week, the FDA cleared oral antivirals from Pfizer and Merck for the treatment of COVID-19. The Biden-Harris administration released the trucking action plan. The CDC approved the ACIP preference recommendation for the Pfizer-BioNTech and Moderna vaccine boosts. The new recommended Tris vaccine buffer leads to greater stability and does not require dilution. Please see details of these and other supply chain developments below:

  • On December 15, the FDA approved Eagle Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for injection of vasopressin (20 units / ml in multidose vials), a product that has grown in demand during the COVID-pandemic. 19. The FDA said that this approval, the first approval from an ANDA for this product, represents the agency’s commitment “to facilitate access to medical products to help meet the critical needs of the American public.”
  • On December 16, the Authority released its Trucking Action Plan to help reduce supply chain disruption as part of initiatives promoted by the Chain Disruption Task Force. supply. Globally, the plan aims to implement measures to reduce barriers to the issuance of commercial driver’s licenses (CDLs); accelerate the learning of trucking; recruit veterans, especially those with previous trucking experience, into the industry; and schedule listening sessions with the current workforce to implement improvement strategies. In order to promote immediate implementation, the plan also includes specific actions for 30, 60 and 90 days to implement the objectives of the plan.
  • On December 16, the FDA approved the use of Tris buffer for the manufacture of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine. This new formulation offers two key advantages to vaccinators: (1) it increases the stability of the vaccine longer at refrigerated temperatures; and (2) it does not require dilution by the supplier before use.
  • On December 16, the CDC approved the Advisory Committee on Immunization Practices (ACIP) recommendations that the Pfizer-BioNTech and Moderna vaccines are preferred for booster use over the Johnson & Johnson vaccine. ACIP met earlier today and based its decision on data including a review of efficacy and adverse events.
  • On December 17, the FDA announced that it was considering a program that would impose sterilization changes to the master file pilot program for 510 (k) approved medical devices. The change applies to the established Category B or to new sterilization methods. In addition to manufacturers in the innovation challenge, current 510 (k) holders can also participate in two previous programs where the FDA (1) has challenged manufacturers to develop new ways to develop alternatives to the ethylene oxide; and (2) reduce emissions of ethylene oxide. If changes are made to sterilization methods when ethylene oxide is used, participants can now refer to their master files instead of submitting a new 510 (k).
  • On December 20, Moderna announced that it was continuing to advance clinical trials to develop an omicron-specific vaccine for use as a booster. He also noted that the antibodies from his 50mcg and 100mcg booster doses demonstrated a 37- and 83-fold increase in antibody levels. Clinical trials of vaccines targeting both omicron and delta are underway.
  • On December 21, the Center for Devices and Radiological Health (CDRH) released a plan for how the CDRH intends to manage reviewer workload in 2022 based on the increase in the total number of submissions. In 2021, the CDRH saw an increase in medical device submissions for approval through the traditional processes, namely the PMA, 510 (k) and Q-sub processes, which it addressed through the implementation of new approaches to review, including triage of cases, reallocation of staff and resources to COVID-19 products, use of contractors and overtime. Despite these approaches, some issues related to meeting review deadlines still need to be addressed. For devices other than in vitro diagnostics, the CDRH expects to be able to comply with the review deadlines of the Medical Device User Fee Agreement (MDUFA) in 2022 despite the influx of medical products subject to review. For in vitro diagnostic products, the CDRH will also try to meet the deadlines promised by the MDUFA. Non-COVID products that were not prioritized during the pandemic will require extended review times. In addition, the pre-submission request program will be reinstated as of January 1, 2022.
  • On December 22, the FDA cleared Pfizer’s oral antiviral drug, Paxlovid, for the treatment of mild to moderate COVID-19 in adults and children 12 years of age or older (weighing 40 kg or more). This is the first oral antiviral treatment for COVID-19 to receive emergency use authorization. The clearance was based on data from the EPIC-HR trial, which demonstrated that Paxlovid significantly reduced hospitalizations and deaths from all causes in the study population compared to those randomized to receive a placebo. Paxlovid is a combination of nirmatrelvir and ritonavir – the former inhibits the replication of SARS-CoV-2 and the latter slows down the breakdown of nirmatrelvir in the body. The FDA will continue to monitor clinical trial data for the safety and effectiveness of the drug.
  • On December 23, the FDA cleared Merck’s oral antiviral drug, molnupiravir, for the treatment of mild to moderate COVID-19 in adults at high risk of progression to severe COVID-19 and for whom options for Alternative treatment to COVID-19 is not available. accessible or clinically appropriate.

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Joan J. Dean

The author Joan J. Dean