FDA Novel drug approvals in 2020 with Vapourtec

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    Every year, the FDA’s Centre for Drug Evaluation and Research (CDER) in the US supports novel treatments for patients by approving new drugs that will provide a better treatment of medical conditions.

    Some of these drugs already have FDA approval and are being repurposed; other drugs are innovative products that gain approval status after passing the scrutiny of clinical trials. In 2020, Artesunate and Remdesivir, two of the 53 approved drugs, were developed at some stage using Vapourtec flow chemistry systems.

    In 2014, Prof. Peter H. Seeberger’s team at the Max Plank Institute of Colloids and Interfaces, developed an inexpensive, large scale, continuous flow synthetic route to produce purified anti-malarial APIs, including Artesunate[1]. They used a Vapourtec R-Series system to develop the modular platform able to carry multi-step reactions coupled to a final purification stage, which provides APIs that meet the WHO and FDA purity guidelines. This patented [2] modular flow approach had several advantages compared to existing batch processes, as it can also produce anti-malarial drugs from extracted by-products that are usually discarded.

    The second approved drug, Remdesivir, has been in vogue recently due to the global COVID-19 pandemic. Gilead originally developed Remdesivir as an anti-viral to treat Ebola outbreaks. In late May 2020, The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved it as the first medicine to treat COVID-19, and it was followed by the FDA approval in late October 2020. In 2020 the Gilead teams in California (US) and Alberta (Canada) published a reliable continuous flow cyanation, that was subsequently used for initial production quantities [3].

    Dr Manuel Nuño of Vapourtec commented: “Having a drug approved by any international body is a lengthy and very expensive process. For every approved new drug, scientists spend years developing and synthesising thousands of different compounds. Few of these potential drug candidates would progress to pre-clinical tests and, only a handful of these will enter clinical trials. The odds of a compound making it to the market are slim indeed.

    “In these times, more than ever, we should celebrate success within the scientific community, and Vapourtec congratulates all the scientists involved. For Vapourtec, having our instrumentation contributing to the development of these two drugs is enough recognition, showing the value our flow chemistry systems can add to research projects.

     

    Drug discovery is never simple, implementing flow chemistry helps in the development of new drug candidates. Easily automated library synthesis, rapid reaction screenings or safe handling of hazardous reagents, just to name a few, are some of the advantages of working with Vapourtec systems.

    References
    [1] K. Gilmore et al., “Continuous synthesis of artemisinin-derived medicines,” Chem. Commun., vol. 50, no. 84, pp. 12652–12655, 2014

    [2]  European patent application number: 13176539.8

    [3] T. Vieira, A. C. Stevens, A. Chtchemelinine, D. Gao, P. Badalov, and L. Heumann, “Development of a Large-Scale Cyanation Process Using Continuous Flow Chemistry En Route to the Synthesis of Remdesivir,” Org. Process Res. Dev., vol. 24, no. 10, pp. 2113–2121, Oct. 2020

    For more information about the Remdesivir work click here

    For more information about the Artesunate work

    For more information about the Flow Chemistry systems used in both cases click here

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