INDIA

ITOLIZUMAB- (ALZUMAb)

Kiran Mazumdar Shaw, Executive Chairperson of Biocon Limited, Bengaluru, announced Monday that it has received the Drugs Controller General of India’s (DCGI) approval to market Itolizumab (ALZUMAb) Injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19.

Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications. Biocon has repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as ALZUMAb® for treating chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to COVID-19.

Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.

The approval of Itolizumab, from the DCGI is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi. The study focussed on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to COVID-19.

The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved. Over 100 people in Maharashtra, Gujarat and Delhi have been cured who were given Itolizumab drug.

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile(SNS) to be distributed and used for certain hospitalized patients with COVID-19. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible. The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions. The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states.
• On March 29, 2020, the FDA issued an immediately in effect guidance that outlines an enforcement policy to help expand the availability and capability of sterilizers, disinfectant devices and air purifiers. The devices include those intended to make devices sterile, kill pathogens or other microorganisms and kill pathogens or microorganisms in the air. This policy reflects FDA’s commitment to ease burdens on health care providers and facilities as they face COVID-19.
• The FDA amended the Emergency Use Authorization (EUA) for the Battelle Decontamination System for use in decontaminating compatible N95 respirators for reuse by health care personnel during the COVID-19 pandemic. This EUA is an important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by medical professionals on the front lines of the COVID-19 pandemic.
• On March 30, 2020, the FDA issued an immediately in effect guidance to help expand the availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon’s and patient examination gloves during this public health emergency.
• FDA and FTC issued warning letters to two companies for selling unapproved products claiming to mitigate, prevent, treat, diagnose or cure COVID-19. One of the companies, Corona-cure.com, was warned for selling the product Coronavirus Infection Prevention Nasal Spray with misleading claims on its website that its product is safe and/or effective for the treatment or prevention of COVID-19. The agencies also warned Carahealth for selling its herbal products, including “Carahealth Immune,” with misleading claims of prevention and/or treatment of COVID-19. We are particularly concerned that unapproved drugs that claim to cure, treat, or prevent serious conditions may cause consumers to delay or stop appropriate medical treatment, leading to serious or life-threatening harm. There is currently no approved treatment or preventative measure for COVID-19. FDA and FTC are closely monitoring social media, the online marketplace, and incoming reports for fraudulent COVID-19 products on the market.
• The FDA issued an updated guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding questions and answers on this subject. We plan to update this appendix as new questions arise. This guidance is intended for industry, investigators and institutional review boards and was issued because we recognize that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products.
• Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 230 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 20 emergency use authorizations have been issued for diagnostic tests, including Abbott Diagnostics Scarborough, Inc., ID NOW COVID-19, a rapid (13 minutes or less) test. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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