By Dr Nicola Davies
Since 2020, the US Food and Drug Administration’s activities have centered around the response to the COVID-19 pandemic.1
The agency closed out 2021 with the approval of two oral antivirals for COVID-19 – Pfizer’s (NYSE: PFE) Paxlovid co-packaged nirmatrelvir and ritonavir tablets and Merck & Co’s (NYSE: MRK) Lagevrio (molnupiravir).2,3 Nevertheless, in addition to these activities, the agency has been working on various non-pandemic-related initiatives. Here, we look at some of the FDA’s planned activities for 2022.
Potential drug approval decisions
Among vaccines for the prevention of COVID-19, the FDA is expected to make a decision regarding the final approval of Moderna’s (Nasdaq: MRNA) elasomeran (Spikevax) in April 2022 and the emergency use authorization of Novavax’ (Nasdaq: NVAX) protein subunit vaccine by the end of 2022.4 Following the 2021 approval of Aduhelm (aducanumab), the first anti-amyloid antibody for Alzheimer’s disease, the FDA approval of two other anti-amyloid antibodies for this disease are anticipated in 2022 – Biogen (Nasdaq: BIIB) and Eisai’s (TYO: 4523) lenacumab and Eli Lilly’s (NYSE: LLY) donanemab. Other drug candidates expected to be reviewed in 2022 include Bristol Myers Squibb’s (NYSE: BMY) anti-cancer drug relatlimab, the first LAG3-targeted checkpoint inhibitor, and Alnylam’s (Nasdaq: ALNY) siRNA therapeutic vutrisiran for the treatment of hereditary transthyretin amyloidosis.
Modernization of data infrastructure
In today’s data-driven world, collecting and processing data from various sources such as routine patient care and clinical evidence is critical for improving healthcare and FDA decision making. Therefore, it is important to update the antiquated methods of data processing currently used by the FDA. To this end, the FDA is planning to undertake a major revamping of the data infrastructure across the agency to keep up with current technological requirements to facilitate speedy drug development and more effective decision making. For example, artificial intelligence can be used for rapid and efficient screening of existing drugs for the identification of potential therapeutic candidates against COVID-19.1
Read rest of article from the Pharma Letter: https://www.thepharmaletter.com/article/fda-the-outlook-for-2022
FDA 2022 publication: https://www.fda.gov/media/149616/download