FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults

– Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 –

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

– Actemra is approved for this use in more than 30 countries for the treatment of COVID-19 –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Actemra^® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.

“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19.”

Four randomized, controlled studies evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. Altogether, the results of these four studies (the University of Oxford-led RECOVERY trial, along with the Genentech-sponsored global trials, EMPACTA, COVACTA and REMDACTA) showed that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. The FDA approval is based on the results from the RECOVERY trial, as well as the EMPACTA trial, the first global, Phase III study in COVID-19 to focus on patients from underrepresented racial and ethnic groups. No new warnings and precautions related to Actemra in COVID-19 studies have been identified. The most common adverse reactions seen (incidence ≥ 3%) are constipation, urinary tract infection, hypertension, anxiety, diarrhea, insomnia and nausea.

The FDA approval follows the FDA’s Emergency Use Authorization (EUA) for Actemra in hospitalized adults and children (ages 2 and older) with COVID-19, which was granted in June 2021. The use of Actemra to treat hospitalized people ages 2 to less than 18 years old is not FDA approved, however the EUA for this age group currently remains in place after the FDA approval for hospitalized adult patients.

Genentech and Roche are committed to providing consistent, uninterrupted patient access to Actemra for all approved indications. The worldwide manufacturing capacity of Actemra has significantly increased in 2022, resulting in all configurations of Actemra IV and Actemra subcutaneous (SC) being available at levels sufficient to meet patient demand. The most up-to-date information about the supply of Actemra in the U.S. can be found here. Actemra SC is not authorized for the treatment of COVID-19 patients.

More than one million people hospitalized with COVID-19 have been treated with Actemra worldwide since the beginning of the pandemic. Around the world, Actemra is approved for use in more than 30 countries for patients hospitalized with severe COVID-19. In the U.S., this is the seventh FDA approved indication for Actemra since the medicine was launched in 2010.

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 United States, European Union, Japan, the United Kingdom, New Zealand, Russia and Brazil, provisionally approved in Australia, and authorized for emergency use in Ghana, Mexico and Korea for defined patients hospitalized with severe or critical COVID-19. It has also been recommended and prequalified by the World Health Organization.

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. Actemra IV is approved for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 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.

IMPORTANT SAFETY INFORMATION ABOUT ACTEMRA FOR COVID-19

ACTEMRA can cause serious side effects

Serious Infections

ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have died from these infections. Your healthcare provider should assess you for TB before starting and during treatment with ACTEMRA (except if you have COVID-19).

Before starting ACTEMRA, tell your healthcare provider if you have:

• an infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Symptoms of an infection, with or without a fever, include sweating or chills; shortness of breath; warm, red or painful skin or sores on your body; feeling very tired; muscle aches; blood in phlegm; diarrhea or stomach pain; cough; weight loss; burning when you urinate or urinating more than normal
• any of the following conditions that may give you a higher chance of getting infections: diabetes, HIV, or a weak immune system
• tuberculosis (TB), or have been in close contact with someone with TB
• live or have lived, or have traveled to certain parts of the United States where there is an increased chance of getting fungal infections. These parts include the Ohio and Mississippi River valleys and the Southwest
• hepatitis B or have had hepatitis B

If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with ACTEMRA.

Who should not take ACTEMRA?

Do not take ACTEMRA if you are allergic to tocilizumab, or any of the ingredients in ACTEMRA.

Be sure to talk to your healthcare provider if you see any signs of these serious side effects:

Tears (perforation) of the Stomach or Intestines

If you have diverticulitis (inflammation in parts of the large intestine), talk to your healthcare provider before taking ACTEMRA. Some people taking ACTEMRA may develop a hole in the wall of their stomach or intestines (also known as a perforation). This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

Tell your healthcare provider right away if you see any of these side effects: fever, stomach-area pain that does not go away, or if you see a change in your bowel habits.

Liver problems (Hepatotoxicity)

Some people have experienced serious life-threatening liver problems, which required liver transplant or led to death. Your healthcare provider may tell you to stop taking ACTEMRA if you develop new or worsening liver problems during treatment with ACTEMRA. Tell your healthcare provider right away if you have any of the following symptoms:

• feeling tired (fatigue)
• lack of appetite for several days or longer (anorexia)
• yellowing of your skin or the whites of your eyes (jaundice)
• abdominal swelling and pain on the right side of the stomach-area
• light colored stools
• weakness
• nausea and vomiting
• confusion
• dark “tea-colored” urine

Changes in Blood Test Results

Your healthcare provider should do blood tests before you start receiving ACTEMRA. These blood tests are to check for the following side effects of ACTEMRA:

• Low neutrophil count: neutrophils are white blood cells that help the body fight infection
• Low platelet count: platelets are blood cells that help with clotting, which stops bleeding
• Increase in liver function test levels
• Increase in blood cholesterol levels: your cholesterol levels should be checked 4-8 weeks after you start receiving ACTEMRA.

Your healthcare provider will determine how often you will have follow-up blood tests. Make sure you get all your follow-up blood tests done as ordered by your healthcare provider.

You should not receive ACTEMRA if your neutrophil and platelet counts are too low or your liver function test levels are too high. Changes in blood test results may cause your healthcare provider to stop your ACTEMRA treatment for a time or change your dose.

Cancer

ACTEMRA may increase your risk of certain cancers by changing the way your immune system works.

Hepatitis B Infection

If you have or are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use ACTEMRA. Your healthcare provider may do blood tests before you start treatment with ACTEMRA and while you are using ACTEMRA. Tell your healthcare provider if you have any signs of these symptoms:

• feel very tired
• skin or eyes look yellow
• little or no appetite
• vomiting
• clay-colored bowel movements
• fevers
• chills
• stomach discomfort
• muscle aches
• dark urine
• skin rash

Serious Allergic Reactions

Serious allergic reactions, including death, can happen with ACTEMRA. These reactions can happen with any infusion or injection of ACTEMRA, even if they did not occur with an earlier infusion or injection. Tell your healthcare provider before your next dose if you had hives, rash or flushing after your injection.

Contact 911 immediately, as well as your healthcare provider if you experience any of these reactions:

• shortness of breath or trouble breathing
• swelling of the lips, tongue, or face
• chest pain
• feeling dizzy or faint
• moderate or severe abdominal pain or vomiting

Nervous System Problems

While rare, Multiple Sclerosis has been diagnosed in people who take ACTEMRA.

The most common side effects of ACTEMRA include:

• upper respiratory tract infections (common cold, sinus infections)
• headache
• increased blood pressure (hypertension)
• injection site reactions

ACTEMRA & Pregnancy

Tell your healthcare provider if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. You and your healthcare provider should decide if you will take ACTEMRA or breast-feed. You should not do both. If you are pregnant and taking ACTEMRA, join the pregnancy registry. The purpose of this registry is to check the health of the pregnant mother and her baby. To learn more, call 1-877-311-8972 or talk to your healthcare provider to register.

Tell your healthcare provider if you have any side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information and the Medication Guide, including Serious Side Effects, for more Important Safety Information.

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. That is why we are working with governments, policy makers, healthcare professionals and others to help contain the COVID-19 pandemic and make sure patients continue to receive the tests, treatment and care they need.

The pandemic has profoundly raised awareness of the role diagnostics play in COVID-19 diagnosis, treatment development and disease management. Genentech has developed and launched more than 20 COVID-19 diagnostics solutions, including polymerase chain reaction (PCR) and rapid antigen and antibody tests. Our solutions serve the entire diagnostic continuum, from high-throughput laboratories to point-of-care and home self-testing, and cover all currently known variants. To help meet global demand, we have supplied more than 1.5 billion tests for COVID-19 since March 2020.

Genentech continues to evaluate its existing therapeutic portfolio and is researching future options to help benefit patients with COVID-19. Our IL-6 inhibitor Actemra has been approved for patients hospitalized with severe COVID-19 in more than 30 countries including the European Union and the United States. The World Health Organization has prequalified Actemra for use in patients with severe COVID-19, facilitating its availability in low- and middle-income countries. In addition, we have been improving access to Actemra by introducing an international differentiated pricing strategy, providing the medicine at cost for use in low- and middle-income countries and non asserting patents in these regions during the pandemic.

Our utmost goal remains to be a trusted partner who acts with urgency to save and improve the lives of patients with COVID-19 and to reduce its burden on society. For more information please visit our COVID-19 response page.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 2 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.

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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