FDA Approves Two Oral COVID-19 Drugs – Medical Product Supply Chain Week in Review | Alston and bird
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 recommendation of preference for the Pfizer-BioNTech and Moderna vaccine boosters. The new recommended Tris vaccine buffer leads to greater stability and requires no 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 vasopressin injection (20 unit/mL multi-dose vials), a product for which demand has increased during the coronavirus pandemic. COVID-19. The FDA said this approval – the first ANDA approval 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 Dec. 16, the Administration released its Trucking Action Plan to help reduce supply chain disruptions 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 licenses (CDLs); accelerate learning in trucking; recruit veterans, especially those with previous trucking experience, into the industry; and plan 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 benefits to vaccinators: (1) it increases vaccine stability for longer at refrigerated temperatures; and (2) it does not require dilution by the supplier before use.
- On December 16, the CDC endorsed the recommendations of the Advisory Committee on Immunization Practices (ACIP) that the Pfizer-BioNTech and Moderna vaccines are preferred for booster use instead of the Johnson & Johnson vaccine. The 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 mandate sterilization changes to the master file pilot program for 510(k) licensed medical devices. The change applies to established Category B or 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 ethylene oxide; and (2) reduce ethylene oxide emissions. 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 to use as a booster. He also noted that antibodies from his 50 mcg and 100 mcg booster doses demonstrated a 37- and 83-fold increase in antibody levels. Clinical trials for vaccines targeting both omicron and delta are underway.
- On December 21, the Center for Devices and Radiological Health (CDRH) released a plan for how CDRH intends to manage reviewer workload in 2022 based on the increase in total submissions. In 2021, CDRH saw an increase in medical device submissions for approval through traditional processes, i.e. PMA, 510(k) and Q-sub processes, which it managed through the implementing new review approaches, including triage of cases, reallocation of staff and resources to COVID-19 products, use of contractors and overtime. Despite these approaches, there remain issues of review timeliness that have yet to be resolved. For devices other than in vitro diagnostics, CDRH expects to be able to meet Medical Device User Fee Agreement (MDUFA) review timelines in 2022 despite the influx of medical products subject to review. For in vitro diagnostic products, CDRH will also attempt to meet the timelines promised by 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 effective January 1, 2022.
- On December 22, the FDA cleared Pfizer’s oral antiviral, Paxlovid, for the treatment of mild to moderate COVID-19 in adults and children 12 years of age or older (weighing at least 40 kg). It is the first oral antiviral treatment for COVID-19 to receive emergency use authorization. The approval was based on data from the EPIC-HR trial, which demonstrated that Paxlovid significantly reduced hospitalizations and deaths from any cause in the study population compared to those randomized to placebo. Paxlovid is a combination of nirmatrelvir and ritonavir – the former inhibits the replication of SARS-CoV-2, and the latter slows the breakdown of nirmatrelvir in the body. The FDA will continue to monitor clinical trial data for the drug’s safety and effectiveness.
- On December 23, the FDA cleared Merck’s oral antiviral, molnupiravir, for the treatment of mild to moderate COVID-19 in adults who are at high risk of progression to severe COVID-19 and for whom alternative options treatments for COVID-19 are not accessible or clinically appropriate.