SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep 30, 2026--

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The filing acceptance is based on data from the comprehensive clinical program, including the Phase III FENhance 1 and 2 RMS studies and the Phase III FENtrepid PPMS study.

"People living with multiple sclerosis need treatments that go beyond controlling relapses to help preserve function and independence as the disease progresses," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Three Phase III studies have demonstrated the potential for fenebrutinib to address both relapsing and progressive disease, thereby bringing us closer to an oral treatment that could make a meaningful difference across the MS spectrum."

“Ocrevus transformed how we treat MS, helping more than 525,000 people live a life less defined by their disease. Yet, over a third of all people with MS still receive lower-efficacy treatment,” said Teresa Graham, Chief Executive Officer, Pharma. “If approved, fenebrutinib could open a new chapter as the first high-efficacy oral therapy for both relapsing and primary progressive MS, helping to control disease activity while giving people more flexibility and choice.”

Concurrently addressing the life-disrupting relapses and long-term disease progression – the slow, steady loss of physical and mental abilities over time – remains one of the greatest challenges in MS. Fenebrutinib is designed to act throughout the body and to cross the blood-brain barrier into the central nervous system to target both the acute inflammation that causes relapses and the chronic inflammation that is thought to drive disability progression.

The NDA for fenebrutinib is supported by three positive Phase III studies:

• The FENhance 1 and 2 RMS studies showed that fenebrutinib significantly reduced relapses and both active and chronic brain lesions compared with standard of care, teriflunomide. Fenebrutinib reduced the annualized relapse rate (ARR) by 51.1% (p<0.001) in FENhance 1 and 58.5% (p<0.00001) in FENhance 2 compared with teriflunomide over 96 weeks. This equates to patients having approximately one relapse every 17 years, which is the lowest relapse rate seen in Phase III MS studies. In addition, measures of disability progression, including 12-week composite confirmed disability progression (cCDP12), showed consistent positive trends favoring fenebrutinib over teriflunomide.
• The FENtrepid PPMS study showed fenebrutinib met its primary endpoint of non-inferiority compared with Ocrevus ® (ocrelizumab), the current standard of care and only approved medicine for PPMS, in reducing disability progression. Fenebrutinib numerically reduced the risk of progression by 12% compared to Ocrevus, as measured by the time to onset of cCDP12 (hazard ratio [HR] 0.88; 95% confidence interval [CI]: 0.75, 1.03), with curves separating as early as 24 weeks. A consistent treatment effect on disability progression was observed across patient subgroups, including those without active inflammation, and for the entire treatment duration after 24 weeks.

The overall rate of serious adverse events for fenebrutinib and teriflunomide, respectively, was 9% and 9% in FENhance 1 and 11% and 6% in FENhance 2. The overall rate of serious adverse events in FENtrepid was 19% for fenebrutinib and 19% for Ocrevus. Liver enzyme elevations were comparable between the fenebrutinib and teriflunomide arms in the RMS studies and observed more often with fenebrutinib compared to Ocrevus in the PPMS study. While an imbalance in reported fatalities was observed across the three pivotal studies, the deaths occurred at different timepoints and had various causes. Overall, fenebrutinib has shown a manageable safety profile across the three Phase III and earlier studies, with a large safety database including more than 2,700 study participants.

About fenebrutinib

Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimized pharmacokinetics (PK) profile. Fenebrutinib can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression.

While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme.

About multiple sclerosis

Multiple sclerosis is a chronic disease that affects more than 3 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.

Approximately 85% of people with multiple sclerosis are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus ®, there had been no FDA-approved treatments for PPMS, and Ocrevus is still the only approved treatment for PPMS.

About Genentech in Neurology

Neurology is a major focus of research and development at Genentech and Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally.

Genentech and Roche are investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today.

About Genentech

Founded 50 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.

Indications and Important Safety Information

What is Ocrevus?

Ocrevus is a prescription medicine used to treat:

• Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
• Primary progressive MS, in adults.
• Relapsing-remitting MS, in children 10 years of age and older who weigh 55 pounds (25 kg) or more.

It is not known if Ocrevus is safe and effective in children younger than 10 years of age or who weigh less than 55 pounds (25 kg).

Who should not receive Ocrevus?

Do not receive Ocrevus if you:

• have an active hepatitis B virus (HBV) infection.
• have had a life-threatening allergic reaction to Ocrevus. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past.

What is the most important information I should know about Ocrevus?

Ocrevus can cause serious side effects, including:

• Infusion reactions: Infusion reactions are a common side effect of Ocrevus, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
  • Itchy skin
  • Rash
  • Hives
  • Tiredness
  • Coughing or wheezing
  • Trouble breathing
  • Throat irritation or pain
  • Feeling faint
  • Fever
  • Redness on your face (flushing)
  • Nausea
  • Headache
  • Swelling of the throat
  • Dizziness
  • Shortness of breath
  • Fatigue
  • Fast heart beat

These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

• Infection:
  • Infections are a common side effect. Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with Ocrevus, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone.
  • Hepatitis B virus (HBV) reactivation: Before starting treatment with Ocrevus, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus.
  • Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with Ocrevus. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
  • Thinking
  • Eyesight
  • Strength
  • Balance
  • Weakness on 1 side of your body
  • Using your arms or legs
• Decreased immunoglobulins: Ocrevus may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you:

• have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS.
• have ever had hepatitis B or are a carrier of the hepatitis B virus.
• have a history of inflammatory bowel disease or colitis.
• have a history of liver problems.
• have had a recent vaccination or are scheduled to receive any vaccinations.
  • You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Ocrevus. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Ocrevus and until your healthcare provider tells you that your immune system is no longer weakened.
  • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Ocrevus. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus, talk to your healthcare provider.
  • If you have a baby and you received Ocrevus during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Ocrevus so they can decide when your baby should be vaccinated.
• are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus will harm your unborn baby. You should use birth control (contraception) during treatment with Ocrevus and for 6 months after your last infusion of Ocrevus. Talk with your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider if you become pregnant while receiving Ocrevus.
• are breastfeeding or plan to breastfeed. It is not known if Ocrevus passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Ocrevus.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of Ocrevus?

Ocrevus may cause serious side effects, including:

• Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
• Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
  • Diarrhea (loose stools) or more frequent bowel movements than usual
  • Stools that are black, tarry, sticky or have blood or mucus
  • Severe stomach-area (abdomen) pain or tenderness
• Liver damage. Ocrevus may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start Ocrevus and while you take Ocrevus if needed. Tell your healthcare provider right away if you have any symptoms of liver damage, such as:
  • yellowing of the skin and eyes (jaundice)
  • nausea
  • vomiting
  • unusual darkening of the urine
  • feeling tired or weak
  • loss of appetite
  • discomfort in the upper right area of stomach (abdomen)

These are not all the possible side effects of Ocrevus.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555.

For more information, go to https://www.Ocrevus.com or call 1-844-627-3887.

For additional safety information, please see the full Prescribing Information and Medication Guide.

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SOURCE: Genentech

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PUB: 09/30/2026 01:00 AM/DISC: 09/30/2026 01:00 AM

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