Business Wire

Biogen Receives Positive CHMP Opinion for TYSABRI® (Natalizumab) Use in Highly Active RRMS Patients with Inadequate Response to Prior MS Therapy

Del

The Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a variation to the marketing authorization of TYSABRI® (natalizumab), Biogen (NASDAQ: BIIB) announced today. The CHMP recommends the approval of TYSABRI for use as a disease modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS) patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT. The positive opinion is supported by long-term real-world experience from the TYSABRI Observational Program (TOP), an ongoing observational, open-label, 10-year prospective study of RRMS patients.

“For nearly 10 years, TYSABRI has provided patients and physicians with a high efficacy therapy that has a well-established tolerability and safety profile,” said Ralph Kern, senior vice president, Worldwide Medical. “This update to the European marketing authorization would allow patients with highly active disease to switch to TYSABRI regardless of the prior DMT used.”

Data Supporting Positive Opinion
The CHMP opinion is based on real-world data from the TOP study. Results from TOP, recently presented at the 68th American Academy of Neurology annual meeting, showed that TYSABRI significantly reduced multiple sclerosis disease activity and demonstrated a favorable benefit-risk profile, regardless of which prior DMT was used. The incidence of reported serious adverse events was consistent with TYSABRI’s known safety profile.

The opinion of the CHMP is now referred to the European Commission (EC) for final decision on approval.

This positive opinion follows April 2016 EC approvals that granted TYSABRI unlimited validity for the marketing authorization in Europe and updated the European Union product information and physician/patient education materials. The new patient management plan provides an updated risk algorithm which allows physicians to have more individualized benefit-risk discussions with their patients and provides them with clear guidelines to manage their patients appropriately.

According to the EMA, the updated risk estimates show that the risk of developing progressive multifocal leukoencephalopathy (PML) is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with TYSABRI for longer than two years. In patients who tested negative for JC virus antibodies, the PML risk estimate remains unchanged at 0.1 per 1,000 patients. Biogen is committed to patient safety and continues to work closely with the scientific community to provide greater clarity on the minimization of risk for patients taking TYSABRI.

About TYSABRI ®
TYSABRI is a disease modifying therapy (DMT) approved in more than 80 countries including the United States, the European Union, Canada, Australia and Switzerland. In the United States, TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis (MS). In the European Union, it is indicated as a single DMT in highly active relapsing-remitting MS (RRMS) for adult patients who have high disease activity despite treatment with a beta interferon or glatiramer acetate or patients with rapidly evolving severe RRMS. TYSABRI is proven effective, with 10 years of experience in treating RRMS, and more than 149,000 people treated worldwide and 475,000 patient-years of experience.

TYSABRI is a monoclonal antibody that selectively binds to α4-integrin and is thought to interrupt the activity of inflammatory cells in MS patients by blocking the interaction between α4β1-integrin and vascular cell adhesion molecule-1. Disruption of these molecular interactions prevents transmigration of leukocytes across the endothelium into inflamed parenchymal tissue. The specific mechanism(s) by which TYSABRI exerts its effects in MS have not been fully defined.

TYSABRI has advanced the treatment of MS patients with its proven ability to slow the progression of disability, reduce relapse rates, and impact the number of MRI brain lesions with a well-characterized safety profile. Data from the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that at two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42 to 54 percent (12-24-week sustained respectively, both p<0.001).

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), a rare opportunistic viral infection of the brain which has been associated with death or severe disability. Risk factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses and clinically significant liver injury has also been reported in the post-marketing setting. Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in MS patients receiving TYSABRI. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in the post-marketing setting.

The overall benefit-risk profile of TYSABRI remains positive. For additional important safety information and the United States Prescribing Information which includes a full list of adverse events, please visit www.tysabri.com or your respective country’s website.

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter.

Safe Harbor
This press release includes forward-looking statements, including statements about the potential therapeutic effects and benefits of and on-going clinical use of TYSABRI. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "will," and other words and terms of similar meaning. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of continued successful commercialization of TYSABRI, which may be impacted by, among other things, intense competition in the MS market, the effectiveness of sales and marketing efforts, problems with the manufacturing process for TYSABRI, the occurrence of adverse safety events, difficulties in obtaining or changes in the availability of reimbursement for TYSABRI and Biogen’s other MS products, failure to obtain regulatory approvals in other jurisdictions, failure to protect intellectual property and other proprietary rights, product liability claims, and the other risks and uncertainties that are described in the Risk Factors section of Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements speak only as of the date of this press release and Biogen assumes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact information

Biogen
MEDIA CONTACT:
Lindsey Smith, +1 781-464-3260
public.affairs@biogen.com
or
INVESTOR CONTACT:
Susan Altschuller, +1 781-464-2442
IR@biogen.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

NMI Agrees to Acquire Creditcall to Expand EMV and Omnichannel Capabilities20.2.2018 13:04Pressemelding

NMI, a leading provider of payments enablement technology for independent sales organizations (ISOs), independent software vendors (ISVs), value-added resellers (VARs) and payment facilitators, today announced it has signed a definitive agreement to acquire Creditcall, an omnichannel payment gateway and EMV solutions provider. With offices in Bristol, England, and New York, and customers throughout many regions of the world, Creditcall will give NMI a global presence and access to new markets. This acquisition will continue to differentiate NMI from traditional payment gateway providers by further expanding its omnichannel and EMV capabilities, creating a one-of-a-kind payment gateway platform supporting all channels of commerce including retail, e-commerce, mobile and unattended. “The payment technology requirements of today’s merchants are more complex than ever—they need to accept and process payments in all sales channels and environments,” said Roy Banks, chief executive officer o

Philip Morris International and Scuderia Ferrari Partner Together to Advance the Vision of a World Free of Tobacco Smoke20.2.2018 13:00Pressemelding

Philip Morris International Inc. (NYSE/Euronext Paris: PMI) and Scuderia Ferrari have extended their partnership until 2021. Their successful collaboration spans more than 40 years. As of today, the partnership will be exclusively focused on advancing the cause of a smoke-free world – a world in which all people who would otherwise continue smoking switch from the most harmful form of nicotine consumption – cigarettes – to scientifically substantiated less harmful alternatives that are smoke-free. “We want to give the world’s 1.1 billion men and women who smoke the opportunity to make better and informed choices. We are committed to use all available resources, including our motorsports related activities, to accelerate momentum around this revolutionary change for the benefit of people who smoke, public health and society at large. We deeply appreciate Scuderia Ferrari’s support in this cause,” said PMI’s Chief Executive Officer, André Calantzopoulos. Creating global awareness of the

Legal & General Announces New Partnership with Technology Partner Slice Labs to Roll Out ‘On-Demand’ Homeshare Insurance20.2.2018 13:00Pressemelding

Legal & General, the FTSE 100 financial services group and leading home insurance provider, has today announced a new technology partnership with Slice Labs Inc with the aim to offer a new on-demand homeshare insurance proposition for customers. The last few years has seen an increase in the popularity of on-demand insurance which allows customers to use a mobile app to purchase insurance to protect their personal belongings, car, or home when ‘at risk’. On-demand insurance offers customers flexibility of cover that is easy and convenient to buy and paying only for what they need when they need it. The partnership with Slice Labs Inc is another step in Legal & General’s commitment to invest in new technology and intend to use Slice Labs Insurance Cloud Services™ (ICS) platform to roll out on-demand homeshare insurance and other products to their customers. Founded in October 2015 Slice Labs provides tailored insurance offerings for home sharing costs. The two companies are, working tog

Wipro Positioned in ‘Winner’s Circle’ of HfS Blueprint Report on Enterprise Blockchain Services 201720.2.2018 12:20Pressemelding

Wipro Limited (NYSE:WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has been positioned in the ‘Winner's Circle’ of Enterprise Blockchain service providers by HfS Research in the market study ‘HfS Blueprint Report on Enterprise Blockchain Services 2017’. This report was authored by Saurabh Gupta, Chief Strategy Officer, HfS Research. In the Enterprise Blockchain Services 2017 Report, HfS evaluated the blockchain capabilities of 21 service providers across the value chain of Strategic Advisory, Prototype Development, Production build and System Integration. The 'Winner's Circle' of the HfS Blueprint represents service providers who excel at both execution and innovation dimensions. The report states that Wipro is a leading blockchain services provider with scale, robust partnership ecosystem, in-house tools and live client engagements. Phil Fersht, CEO, HfS Research said, “The blockchain mo

Jetcraft Opens First London Office20.2.2018 10:55Pressemelding

Jetcraft, the global leader in business aircraft sales and acquisitions, announces the opening of its first London office through its new UK company, Jetcraft Global (UK) Limited. The new London base cements Jetcraft’s commitment to the European region and demonstrates its confidence in the UK as a continuing hub of business opportunity. Chad Anderson, President at Jetcraft, says: “The opening of our London office comes as Jetcraft celebrates another record year -- with 93 transactions completed in 2017 – and rounds off a remarkable decade of more than 550 transactions exceeding $10bn in value. Our new London location creates even more ways for us to serve our clients and we are excited about the opportunities it presents.” Jetcraft’s new office comes at a time of significant growth in resources for the company, with the appointment of four senior sales posts from within the team, including Sean O’Leary, who will take on the role of Sales Director based in the new London office. Additi

Inmarsat Selects Sigma Systems for Large-Scale BSS Transformation20.2.2018 10:00Pressemelding

Sigma Systems, the global leader in catalog-driven software, is pleased to announce a multi-year contract with Inmarsat, the leading provider of global mobile satellite communications services. With the digital revolution moving forward at great speed, Inmarsat recognized that a catalog-driven, agile approach to B/OSS was key to enabling more effective connections with their customers and partners through the products and services they sell. To this end, Inmarsat awarded Sigma a multi-year contract for its Catalog, CPQ (Configure Price Quote) and Order Management products to support Inmarsat’s next-generation satellite services across all customer verticals. Kirk Wilkenson, VP OneIT Programme at Inmarsat, commented: “Inmarsat is focused on driving customer value and making it simpler for customers and partners to work with us. We are launching a new B/OSS platform, utilizing a service-oriented component architecture, as part of a broader service delivery transformation to support our c