HCQ is a drug that has long been used for the treatment of malaria and certain autoimmune diseases such as systemic lupus erythematosis and rheumatoid arthritis in adults.1
Why is there so much interest in HCQ?
Based on preliminary medical evidence from researchers, there is interest in evaluating HCQ, and multi-drug combinations, as a potential treatment for COVID-19.2 HCQ has also demonstrated antiviral activity against the virus that causes COVID-19 (SARS-CoV-2) in laboratory tests.3,4 The medicine is currently under investigation in multiple large- and small-scale clinical trials to generate the necessary evidence for regulatory approval and generally accepted treatment guidelines.
Is HCQ safe and effective as a COVID-19 treatment?
The medical evidence at this point is preliminary and requires additional information to ensure that HCQ is effective and safe for this new indication. Several clinical trials assessing the safety and efficacy of HCQ in hospitalized COVID-19 patients are underway. Clinical trials are scientific studies conducted to find better ways to prevent, screen for, diagnose, or treat disease.5 The US Food and Drug Administration (US-FDA) authorized the temporary emergency use of HCQ during the pandemic for treatment of hospitalized COVID-19 patients when clinical trials are not available, or participation is not feasible.6
Is Novartis working with the FDA in conducting the HCQ clinical trials?
Yes, Novartis has reached an agreement with the US-FDA to proceed with a Phase III clinical trial in the US with approximately 440 patients to evaluate the use of HCQ for the treatment of hospitalized COVID-19 patients. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis.7 We will report the results of the clinical trial as soon as these become available.
Is it true that Novartis is donating HCQ globally?
Yes, Novartis, through Sandoz, has made a global commitment to donate up to 130 million tablets of HCQ to supply global clinical research efforts. We donated HCQ to the Philippine Government in response to the request of the Department of Health (DOH). The donation aims to provide a potential treatment for hospitalized COVID-19 patients in the country, following the Philippine Society of Microbiology and Infectious Disease (PSMID) Treatment Guidelines for COVID-19,8 and to advance responsible clinical research on COVID-19.