• RYSTIGGO is now commercially available by prescription in the United States for adult patients with gMG who are anti-acetylcholine receptor(AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive¹
• RYSTIGGO is the first and only FDA-approved targeted treatment for both anti-AChR Ab+ and anti-MuSK Ab+ adults with gMG¹
• ONWARD™, a personalized patient support program, is available to eligible patients and caregivers to provide support during treatment with UCB rare disease medicines, including RYSTIGGO.

ATLANTA, GA, July 21, 2023 – UCB, a global biopharmaceutical company, today announced that RYSTIGGO is commercially available for the treatment of adult patients in the U.S. with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor(AChR)  or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. RYSTIGGO was approved under Priority Review by the U.S. Food and Drug Administration (FDA) on June 26, 2023.²

RYSTIGGO is an HCP-administered injection, for subcutaneous use. RYSTIGGO can be ordered from a limited, defined specialty distribution network. UCB also offers the “UCB Infusion Finder”, an online search tool providing a non-exhaustive listing of approximately 1,000 infusion locations nationwide. RYSTIGGO will have options for infusion at multiple sites of care, including physicians’ offices, hospital outpatient clinics, and independent infusion centers. UCB is partnered with a limited network of specialty pharmacies with home infusion capabilities to support eligible patients with administration in the home setting.³ 

Myasthenia gravis is a rare, chronic, autoimmune neuromuscular disease, which is characterized by muscle weakness that worsens after periods of activity and improves after periods of rest.^4,5 In the U.S., there are 35,000 to 60,000 people living with myasthenia gravis who experience a variety of symptoms, including drooping eyelids, double vision, and difficulty in swallowing, chewing, and talking.⁶ Exacerbations are unpredictable and are characterized by potentially severe symptoms affecting activities of daily living.⁷

“Now that RYSTIGGO is FDA-approved and commercially available, we are committed to advancing access to the care and support journey of eligible patients. This is so important because we know there is a high unmet need for personalized rare disease support,” said Kimberly Moran, Ph.D., Head of U.S. Rare Diseases. “That’s why we co-created ONWARD with the help of patients and healthcare providers from the myasthenia gravis community to help them manage living with this rare disease.”

UCB is offering ONWARD to support eligible patients get started on their prescribed treatment. The patient will be paired with a dedicated Care Coordinator, who will help them understand their coverage and explain potential financial assistance options that could help. The program is currently open for enrollment for eligible patients living in the U.S. Patients interested in learning more about ONWARD should visit www.UCBONWARD.com or call 1-844-ONWARD.⁸

“For many people, myasthenia gravis is a chronic illness that continues to be overwhelming to patients due to function loss and inadequate control of symptoms,” said Samantha Masterson, CEO & President of Myasthenia Gravis Foundation of America.“An additional FDA-approved targeted treatment that is now available provides a new option to eligible patients and their treating physicians who have not yet found an option that works for their needs.”

Affordability and access are important when talking about rare disease treatment. If an eligible patient or caregiver is looking for support,  please visit www.UCBONWARD.com or call 1-844-ONWARD.

About Generalized Myasthenia Gravis 
Generalized myasthenia gravis is a rare disease with a global prevalence of 100–350 cases per every 1 million people.^5,7 People living with generalized myasthenia gravis can experience a variety of symptoms, including muscle weakness, drooping eyelids, double vision, and difficulty with speech, swallowing or talking.⁶

About RYSTIGGO®(rozanolixizumab-noli)
RYSTIGGO is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are acetylcholine receptor (anti-AChR) antibody positive or muscle-specific tyrosine kinase (anti-MuSK) antibody positive. 

IMPORTANT SAFETY INFORMATION 
Infection: RYSTIGGO may increase the risk of infection. In clinical studies, the most common infections were upper respiratory tract infections, COVID-19, urinary tract infections, and herpes simplex infections. Your healthcare provider should check you for infections before starting and during treatment with RYSTIGGO. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with RYSTIGGO. Some of the signs and symptoms may include fever, chills, frequent and/or painful urination, cough, runny nose, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.

Aseptic Meningitis: RYSTIGGO could cause aseptic meningitis. Tell your healthcare provider right away if you develop any signs or symptoms of meningitis during treatment with RYSTIGGO such as severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting.

Hypersensitivity Reactions: RYSTIGGO can cause swelling and rash. Your healthcare provider should monitor you during and after treatment and discontinue RYSTIGGO if needed. Tell your healthcare provider immediately about any undesirable reactions you experience after administration.

Before taking RYSTIGGO, tell your healthcare provider about all of your medical conditions, including if you have a history of infection or think you have an active infection or have received or are scheduled to receive a vaccine (immunization). The use of vaccines during RYSTIGGO treatment has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with RYSTIGGO. Completion of age-appropriate vaccines according to vaccination guidelines before starting a new treatment cycle with RYSTIGGO is recommended.

Before taking RYSTIGGO, tell your healthcare provider if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

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

The most common side effects of RYSTIGGO include headache, infections, diarrhea, fever, hypersensitivity reactions, and nausea.

These are not all of the possible side effects of RYSTIGGO. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UCB, Inc. by calling 1-844-599-CARE [2273].

Please see the full Prescribing Information and talk to your healthcare provider about your condition or your treatment. For more information, go to www.RYSTIGGO.com or call 1-844-599-2273.

For further information, contact UCB: 

U.S. Rare Disease Communications
Daphne Teo
+1-770-880-7655
daphne.teo@ucb.com

Global Rare Disease Communications
Jim Baxter
T+32.2.473.78.85.01 
jim.baxter@ucb.com  

Corporate Communications, Media Relations
Laurent Schots 
T+32.2.559.92.64  
laurent.schots@ucb.com  

Investor Relations
Antje Witte         
T +32.2.559.94.14 
antje.witte@ucb.com

About UCB 

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements 

This press release may contain forward-looking statements including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems. 

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. 

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. 

References

1. RYSTIGGO. [Prescribing Information] Smyrna, GA: UCB, Inc.
2. UCB press release. www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-us-fda-approval-of-rystiggo-rozanolixizumab-noli-for-the-treatment-of-adults-with-generalized-myasthenia-gravis. Accessed June 27, 2023; and www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761286
3. UCB data on file
4. National Institute of Neurological Disorders and Stroke. What is Myasthenia Gravis. www.ninds.nih.gov/health-information/disorders/myasthenia-gravis. Accessed July 2023.
5. Punga AR, Maddison P, Heckmann JM, Guptill JT, Evoli A. Epidemiology, diagnostics, and biomarkers of autoimmune neuromuscular junction disorders. Lancet Neurol. 2022;21(2):176-188. doi:10.1016/S1474-4422(21)00297-0
6. Howard, James F. Myasthenia Gravis Foundation of America. Clinical Overview of MG. https://myasthenia.org/Professionals/Clinical-Overview-of-MG. Accessed July 2023
7. Bril V. Efficacy and safety of rozanolixizumab in patients with generalised myasthenia gravis: a randomised, double-blind, placebo-controlled, adaptive Phase 3 study MyCarinG study. Lancet Neurol. 2023;22(5):383-94.
8. ONWARD is provided as a service of UCB and is intended to support the appropriate use of UCB medicines. Some program and eligibility restrictions may apply.

RYSTIGGO^® is a registered trademark, and ONWARD™ is a trademark, of the UCB Group of Companies.
©2023 UCB, Inc., Smyrna, GA 30080. All rights reserved. US-P-RZ-MG-2300152