U.S. FDA Grants Priority Review to Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults

– If approved, Actemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalized patients –

– Since the beginning of the pandemic, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide –

– Actemra was previously granted Emergency Use Authorization for the treatment of COVID-19 in hospitalized adults and children –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra^® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). A decision on U.S. FDA approval is expected in the second half of this year.

“The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalized with COVID-19,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “More than one million people with severe or critical COVID-19 have already been treated with Actemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”

The sBLA submission is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. Altogether, the results of these four studies (EMPACTA, COVACTA, REMDACTA and RECOVERY) suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. One of these studies, EMPACTA, was the first global, Phase III study to focus on patients from underrepresented racial and ethnic groups. There have been no new safety signals identified for Actemra in these studies. The most common adverse reactions seen (incidence ≥ 3%) are constipation, anxiety, diarrhea, insomnia, hypertension and nausea.

In June 2021, Actemra received Emergency Use Authorization (EUA) from the U.S. FDA, and is currently approved for use in 16 countries around the world for defined patients hospitalized with severe or critical COVID-19. In February 2022, the World Health Organization (WHO) prequalified Actemra for patients with severe or critical COVID-19, supporting access to care in low- and middle-income countries.

Following the emergence of the SARS-CoV-2 variant of concern, Omicron (B.1.1.529), in December 2021 WHO reported that interleukin-6 receptor blockers, such as Actemra, are expected to still be effective for managing patients with severe COVID-19.

Genentech and Roche are closely monitoring the Actemra supply situation and are seeing progress toward consistent, uninterrupted patient access to Actemra IV. The changing nature of the pandemic may continue to impact the availability of Actemra subcutaneous (SC) and IV formulations. The most up-to-date information about the supply of Actemra in the United States can be found here. Actemra SC is not authorized for the treatment of COVID-19 patients under the EUA.

Genentech stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic.

About Actemra in COVID-19

Actemra is approved for use in multiple territories including the European Union, Japan, Bolivia, Chile, Guatemala, Ecuador, Honduras, Hong Kong, Myanmar, Peru, Philippines, the United Kingdom and Ukraine, provisionally approved in Australia, and authorized for emergency use in Ghana, Korea and the United States for defined patients hospitalized with severe or critical COVID-19. It has also been recommended and prequalified by the World Health Organization.

About the Actemra COVID-19 Clinical Trial Program

Genentech’s clinical trial program evaluated the safety and efficacy of Actemra in hospitalized patients with COVID-19. Actemra is not FDA-approved for this use and there is limited information known about the safety or effectiveness of using Actemra to treat people in the hospital with COVID-19. COVACTA and EMPACTA were the first two global Phase III, multicenter, randomized, placebo-controlled studies of Actemra in patients hospitalized with COVID-19 associated pneumonia. COVACTA was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services (HHS). EMPACTA aimed to address research questions about the safety and efficacy of Actemra in underserved populations by emphasizing enrollment from minority patients often underrepresented in clinical trials. Both studies were published in the New England Journal of Medicine. Genentech also partnered with Gilead Sciences, Inc., on REMDACTA, a Phase III, randomized, double-blind, multicenter study to evaluate the safety and efficacy of Actemra plus Veklury^® (remdesivir), versus placebo plus Veklury, in hospitalized patients with severe COVID-19 associated pneumonia.

About the Emergency Use Authorization (EUA) for Actemra

Actemra has not been approved by the U.S. FDA in this setting, but the FDA has made Actemra available under an emergency access mechanism called an EUA as a treatment for certain patients with COVID-19. There is limited information known about the safety or effectiveness of using Actemra to treat people in the hospital with COVID-19. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. The authorization is temporary and does not replace the formal review and approval process, which is being pursued. Actemra is authorized under the EUA only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Actemra under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Actemra

Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA), for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA, GCA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.

Actemra is intended for use under the guidance of a healthcare practitioner.

About Genentech’s Response to the COVID-19 Pandemic

As a leading healthcare company, we are doing all we can to support countries in their fight against COVID-19 and minimizing its impact. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection, as well as providing digital support to healthcare systems. We also continue to identify, develop, and support therapies that can play a role in treating the disease.

The impact of COVID-19 goes beyond those who contract it. That is why we are working with healthcare providers, laboratories, authorities, and organizations to help make sure patients continue to receive the tests, treatment and care they need during these challenging times. Building on a longstanding tradition of partnerships, we are working together with governments and others to make healthcare stronger and more sustainable in the future.

Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic and Genentech has so far launched 21 diagnostics solutions to help minimize the impact of COVID-19. As soon as the novel SARS-CoV-2 virus was sequenced in early 2020, we got to work. On March 13, 2020 we became the first company to receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a high-volume molecular test to detect the virus. Since then, we have continued to add a range of diagnostics solutions to our global portfolio to help in the fight against COVID-19. In addition to the gold standard PCR test, we have developed antigen tests to help diagnose the virus in settings where there is limited molecular laboratory infrastructure, rapid antigen tests where the virus can be detected on the spot, tests that can test for both flu and COVID-19 at the same time, both high throughput and at the point of care, and tests that can detect virus antibodies that can help monitor the spread of the virus and can also support in vaccine development. In March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations.

Aside from these tests we have also looked at how we can support care for patients who have COVID-19, receiving an U.S. FDA EUA for the Elecsys^® IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, a digital algorithm that could help simplify the screening, diagnosis, and monitoring of respiratory-compromised patients with COVID-19. Genentech is working closely with governments and health authorities around the world and has significantly increased production to support availability of tests globally.

Genentech is also actively involved in understanding the potential of the existing pharmaceuticals portfolio and is researching options for the future. In 2020, Genentech entered into a number of new partnerships, including with Regeneron and Gilead to develop, manufacture and distribute molecules that can potentially both treat and prevent COVID-19.

Genentech entered a partnership with Regeneron to jointly develop Ronapreve™ (casirivimab and imdevimab, known as REGEN-COV™ in the United States). The antibody combination has been approved for use in the European Union, Japan, New Zealand and Switzerland, conditionally approved in Australia and the United Kingdom, and authorized for emergency or temporary pandemic use in additional territories such as Canada and the United States. It has also been conditionally recommended by the World Health Organization for the treatment of patients with COVID-19.

For more information on how Genentech is responding to the global COVID-19 pandemic, please visit our COVID-19 response page.

IMPORTANT INFORMATION ABOUT ACTEMRA FOR COVID-19

AUTHORIZED USE

ACTEMRA is authorized for emergency use under an Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving corticosteroids and who require supplemental oxygen, or a machine that helps with their breathing (ventilator) or a machine that adds oxygen to the blood outside the body (extracorporeal membrane oxygenation or ECMO).

ACTEMRA is not FDA-approved for this use. There is limited information known about the safety or effectiveness of using ACTEMRA to treat people in the hospital with COVID-19. The safety and effectiveness of ACTEMRA have not been studied in pediatric patients hospitalized with COVID-19.

The EUA for ACTEMRA is in effect for the duration of the COVID-19 declaration justifying emergency use of this product, unless terminated or revoked (after which the products may no longer be used under the EUA).

IMPORTANT SAFETY INFORMATION ABOUT ACTEMRA FOR COVID-19

ACTEMRA can cause serious side effects. The most important side effects include:

• Serious infections
• Tears (perforation) of the stomach or intestines
• Liver problems (hepatotoxicity)
• Changes in certain laboratory test results including low neutrophil (white blood cells that help the body fight off bacterial infections) or platelet (blood cells that help with blood clotting and stop bleeding) counts or high liver function tests
• Allergic reactions: If a patient has symptoms such as rash, swelling of their lips, tongue, or throat, or hives (raised red patches of skin that are often very itchy) they should tell their doctor or nurse. This may mean the patient is having an allergic reaction.
• Nervous system problems

The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

Patients should not receive ACTEMRA if they are allergic to tocilizumab or if they have had a bad reaction to ACTEMRA previously.

ACTEMRA & pregnancy:

There is limited experience giving ACTEMRA to pregnant women or breastfeeding mothers. ACTEMRA may harm the patient’s unborn baby. It is unknown if ACTEMRA passes into a patient’s breast milk. If a patient is pregnant or breastfeeding, they can discuss their options and specific situation with their doctor.

If a patient is pregnant or becomes pregnant while taking ACTEMRA, they should join the pregnancy registry. To learn more, patients can call the registry at 1-877-311-8972 or talk to their doctor to enroll.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Please see additional information in Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers, and FDA Letter of Authorization.

For more Important Safety Information please see the full Prescribing Information and Medication Guide, including SERIOUS SIDE EFFECTS.

Important Safety Information for FDA-Approved Indications

Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.

Actemra can cause other serious side effects. These include:

• Tears of the stomach or intestines
• Liver problems (hepatotoxicity)
• Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
• An increased risk of certain cancers by changing the way a patient’s immune system works
• Hepatitis B infection
• Serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection. If a patient has had hives, a rash, or experienced flushing after injecting, the patient should tell their doctor or nurse before their next injection
• Nervous system problems

Patients should not receive Actemra if they are allergic to Actemra or if they have had a bad reaction to Actemra previously.

Most common side effects in patients treated with Actemra:

Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away:

• Upper respiratory tract infections (like common cold and sinus infections)
• Headache
• Increased blood pressure (also called hypertension)
• Injection site reactions

Actemra & pregnancy:

Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed. Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or http://www.FDA.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Please visit http://www.actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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