Novartis Reached An Agreement With The US FDA To Start A Large Phase III Clinical Trial-antimalarial Drug Hydroxychloroquine To Treat Inpatients!

- Mar 20, 2020-

At present, the outbreak of new coronary pneumonia in foreign countries is still spreading rapidly. According to Baidu's "Real-time Big Data Report on New Coronavirus Pneumonia Epidemic Situation", as of 24:00 on April 20, 2020, there were more than 2.43 million cases diagnosed globally, more than 2.35 million cases diagnosed abroad, and more than 162,000 deaths. In the United States, more than 677,000 cases have been diagnosed and 40,000 deaths have occurred.

The situation of the new crown epidemic is unprecedented and severe. Governments of various countries are urgently authorizing the use of potential drugs / therapies for the treatment of severe new coronary pneumonia, including antiviral drugs, antimalarial drugs, anti-inflammatory drugs, plasma during rehabilitation, blood purification technology, etc.

Recently, Novartis announced that it has reached an agreement with the US Food and Drug Administration (FDA) to conduct a phase III clinical trial to evaluate the use of hydroxychloroquine (hydroxychloroquine) for the treatment of new coronavirus pneumonia (COVID-19 ) The efficacy of inpatients. The trial will enroll approximately 440 patients, and hydroxychloroquine will be provided by Sandoz, a generic and biosimilar division of Novartis.

For a long time, hydroxychloroquine has been used to treat malaria and certain autoimmune diseases. The initial prospects of hydroxychloroquine in small-scale clinical studies, including the combination with the antibiotic azithromycin, have aroused interest in the medical community. In addition, hydroxychloroquine has shown antiviral activity against a new coronavirus (SARS-CoV-2) in laboratory tests. Hydroxychloroquine is a derivative of chloroquine. The structure of the two is similar and the mechanism of action is very similar, but in terms of safety and tolerability in clinical use, hydroxychloroquine is significantly improved compared with chloroquine.

At the end of March this year, the US FDA issued an Emergency Use Authorization (EUA) to use hydroxychloroquine and chloroquine for the treatment of new coronavirus pneumonia (COVID-19). In addition, the World Health Organization (WHO) also launched a clinical trial in March to test four of the most promising drugs against COVID-19, including hydroxychloroquine and chloroquine, and the other two drugs are redox Remdesvir and the HIV drug lopinavir / ritonavir (lopinavir / ritonavir, Kreiz). At present, anecdotal evidence shows that these four drugs are effective for the treatment of new coronavirus (SARS-CoV-2).

The large trial sponsored by Novartis will be conducted in more than a dozen clinical treatment centers in the United States. The company plans to start the registration of this study in the next few weeks and is committed to reporting the results as soon as possible. In order to assist in the widespread acquisition of hydroxychloroquine as soon as possible under these special circumstances, Novartis will use non-exclusive voluntary licenses, appropriate exemptions, or similar mechanisms to place any intellectual property rights related to the application or treatment of hydroxychloroquine within the control of Novartis.

John Tsai, Novartis ’global head of drug development and chief medical officer, said:" We have recognized the importance of answering the scientific question of whether hydroxychloroquine is beneficial to patients with COVID-19. We have quickly mobilized to mobilize The placebo-controlled phase III study addressed this problem. "

As the new coronavirus (SARS-CoV-19) continues to spread and kill lives worldwide, doctors and patients are eager to have treatment options. In some cases, clinicians are evaluating drugs that have been approved for other diseases, hoping that these drugs will also fight COVID-19.

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In this phase III clinical trial initiated by Novartis, patients will be randomly divided into three groups. The first group received hydroxychloroquine, the second group received hydroxychloroquine combined with the antibiotic azithromycin, and the third group received placebo. Patients in all treatment groups received standard care of COVID-19. Novartis researchers compressed months of work into weeks to design this large-scale clinical trial to quickly respond to COVID-19 disease treatment needs.

This clinical trial complements a Novartis commitment that if hydroxychloroquine proves to be beneficial for COVID-19 treatment, up to 130 million tablets of hydroxychloroquine will be donated to the world through Sandoz. Currently, Sandoz has donated 30 million tablets of hydroxychloroquine to the US Department of Health and Human Services (HHS), and shipped to other countries in accordance with the requirements of governments around the world.

Sandoz CEO Richard Saynor said: "We are donating hydroxychloroquine tablets for COVID-19 patients, including for this and other clinical trials, and hope that researchers and medical workers can quickly and scientifically determine whether hydroxychloroquine is It can help patients around the world to fight this disease. We will continue to fulfill existing customer orders to ensure that our patients can still obtain the drug, and these patients rely on the drug for other indications. "

As part of its research and development commitment, Novartis has established a clinical investigation team to provide fast access to approved clinical applications, and supports the re-use of Novartis ’drugs for clinical evaluation to meet the needs of COVID-19 patients. In addition to hydroxychloroquine, Novartis also plans to sponsor or co-sponsor clinical trials to study JAK1 / 2 inhibitor ruxolitinib and IL-1β monoclonal antibody canakinumab for COVID-19 hospitalized patients. Requests for approved clinical trials initiated by the investigator include investigations related to the clinical studies of ruxolitinib, canakinumab, imatinib mesylate, secukinumab, hydroxychloroquine, and valsartan in the treatment of COVID-19. (