- Full analysis of Phase 3b NOVA study provides insights on efficacy of every six-week dosing with natalizumab as compared to the approved every four-week dosing
- Real-world analysis shows significantly lower risk of relapse for patients treated with TYSABRI® compared to Ocrevus® (ocrelizumab)
- New data from EVOLVE-MS-2 demonstrate that a favorable gastrointestinal (GI) tolerability profile for VUMERITY® (diroximel fumarate) is achieved and maintained with dose titration
“Our focus on improving the MS patient experience continues to shape research initiatives across Biogen’s MS portfolio, as demonstrated by presentations at this year’s ECTRIMS meeting,” said
Additional Secondary Endpoints and Exploratory Outcomes from Full NOVA Study Include Evaluation of NEDA and EDSS With Q6W Natalizumab
New late-breaking data from the Phase 3b NOVA study provide additional insights into the efficacy of every six-week (Q6W) 300mg natalizumab IV administration compared to the approved every four-week (Q4W) dose of TYSABRI (n=499) for relapsing-remitting multiple sclerosis. Topline results from the NOVA study were released in
- Time to first relapse was similar between the two dosing schedules with the proportion who were relapse-free at 72 weeks at 96.9 percent for Q6W and 97.6 percent for Q4W.
- The proportion of patients free of disability worsening was 90.0 percent in the Q6W arm and 92.0 percent in the Q4W arm.
- Disease activity rates were similar between both groups. The proportion of patients with No Evidence of Disease Activity (NEDA) was 70.0 percent for Q6W and 67.4 percent for Q4W. NEDA was defined as no gadolinium enhancing (Gd+) lesions, no new or newly enlarging T2 hyperintense lesions, no relapse and no 24-week confirmed disability worsening (CDW) at 72 weeks. Patients with one or more missing assessments were counted as having not achieved NEDA.
- The safety findings in the NOVA study were consistent with the known safety profile of IV natalizumab, and the incidence of AEs and SAEs were similar between the two treatment arms. One patient with asymptomatic progressive multifocal leukoencephalopathy (PML) in the Q6W arm was high-risk based on the known risk factors, underscoring the importance of the need for continued PML monitoring and risk factor considerations in patients treated with natalizumab.
“Upon complete evaluation of the NOVA data, the results inclusive of secondary and exploratory outcomes offer a more comprehensive understanding of the six-week dosing regimen of natalizumab and its ability to provide a high level of efficacy in controlling MS disease activity,” said
The NOVA study was designed to assess the efficacy of Q6W dosing with natalizumab IV administration following analyses from the TOUCH (TYSABRI Outreach: Unified Commitment to Health) Prescribing Program, which showed that extended interval dosing was associated with a significant reduction in the probability of PML.4 Natalizumab is available commercially under the brand name TYSABRI and the only approved dose is 300mg on a Q4W regimen.
A Real-world Analysis Reports Lower Relapse Risk With TYSABRI Than Ocrevus
A new analysis of relapse-related outcomes and healthcare utilization for MS patients being treated with disease-modifying therapies (DMTs) found that those treated with TYSABRI (n=835) had a lower risk of relapse than those treated with Ocrevus (n=3,497). The retrospective analysis of data from a
- The probability of remaining free of any relapse was significantly higher with TYSABRI than with Ocrevus at 12 and 24 months (p<0.001);
- Time to first relapse significantly favored TYSABRI over Ocrevus for any relapse (hazard ratio [HR]=0.70; p<0.01) and outpatient relapse (HR=0.71; p<0.01);
- Time to hospitalized relapse was numerically better for TYSABRI compared to Ocrevus but did not differ significantly between treatments (HR=0.61; p=0.11);
- There were no significant differences in annualized costs for relapse-related hospital encounters or steroid use observed between the two treatments and time to first MS-related ER visit did not differ significantly between treatments (HR=1.05; p=0.81).
New EVOLVE-MS-2 Study Results Suggest Consistent GI Tolerability for VUMERITY Throughout Dose Titration May Prevent Delays in Reaching Maintenance Dose
In the Phase 3 EVOLVE-MS-2 study, VUMERITY (n=253) demonstrated that an improved GI tolerability profile compared to TECFIDERA® (dimethyl fumarate) (n=251) may simplify initiation of therapy. A new analysis presented at the meeting examines GI tolerability during the dose titration period and during the maintenance dose period over the course of the study for individuals starting therapy on VUMERITY relative to TECFIDERA. In addition to reinforcing VUMERITY’s tolerability profile based on less frequent and less severe GI events versus TECFIDERA, key findings include:
- Weekly incidence of GI adverse events (AEs) remained consistent and low throughout the 5-week treatment period for VUMERITY but increased in number and severity for TECFIDERA after titration to the full dose, peaking in Weeks 3 and 4.
- Throughout the 5-week treatment period, moderate/severe GI AEs were less likely with VUMERITY (1.6%–4.8% versus 4.4%–13.9% with TECFIDERA).
- Discontinuations due to GI AEs were 0.8 percent for VUMERITY and 4.8 percent for TECFIDERA; most TECFIDERA discontinuations occurred in Week 3 (58.3 percent)
“These findings suggest GI tolerability is consistent across the doses with VUMERITY, which may enable patients to potentially reach the maintenance dose with less dose interruptions,” said
Data Presentations Featured at ECTRIMS:
- Primary Results of NOVA: A Randomised Controlled Study of the Efficacy of 6-Week Dosing of Natalizumab Versus Continued 4-Week Treatment for Multiple Sclerosis (P970)
- Claims-based Relapse and Hospitalisation Rates in Patients With Multiple Sclerosis Treated With Natalizumab or Ocrelizumab (P833)
- Comparing the Impact of Dose Titration on Gastrointestinal Tolerability: Diroximel Fumarate Versus Dimethyl Fumarate in Patients With Relapsing-Remitting Multiple Sclerosis (P692)
About TYSABRI® (natalizumab)
TYSABRI is a well-established treatment indicated for relapsing forms of multiple sclerosis (MS) in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses. In the
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 the 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. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.
TYSABRI also increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses, and serious, life-threatening and sometimes fatal cases have been reported in the post-marketing setting in MS patients receiving TYSABRI. Clinically significant liver injury, including acute liver failure requiring transplant, has also been reported in the post-marketing setting. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis), and infections including opportunistic infections, and a reduction in blood platelet counts.
Please click here for Important Safety Information, including Boxed Warning, and full Prescribing Information, including Medication Guide for TYSABRI in the
About VUMERITY® (diroximel fumarate)
VUMERITY is an oral fumarate with a distinct chemical structure from TECFIDERA® (dimethyl fumarate), approved in the
VUMERITY is contraindicated in patients with known hypersensitivity to diroximel fumarate, dimethyl fumarate or to any of the excipients of VUMERITY; and in patients taking dimethyl fumarate. Serious side effects for VUMERITY are based on data from dimethyl fumarate (which has the same active metabolite as VUMERITY) and include anaphylaxis and angioedema, progressive multifocal leukoencephalopathy, which is a rare opportunistic viral infection of the brain that has been associated with death or severe disability, a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. The most common adverse events, obtained using data from dimethyl fumarate (which has the same active metabolite as VUMERITY), were flushing, abdominal pain, diarrhea and nausea.
Please click here for Important Safety Information and full Prescribing Information, including Patient Information for VUMERITY in the
About TECFIDERA® (dimethyl fumarate)
TECFIDERA, a treatment for relapsing forms of multiple sclerosis (MS) in adults, is the most prescribed oral medication for relapsing MS in the world and has been shown to reduce the rate of MS relapses, slow the progression of disability and impact the number of MS brain lesions, while demonstrating a well-characterized safety profile in people with relapsing forms of MS. TECFIDERA is approved in 69 countries, and more than 530,000 patients have been treated with it, representing more than 1,000,000 patient-years of exposure across clinical trial use and patients prescribed TECFIDERA.6
TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Serious side effects include anaphylaxis and angioedema, and cases of progressive multifocal leukoencephalopathy, a rare opportunistic viral infection of the brain which has been associated with death or severe disability, have been seen with TECFIDERA patients in the setting of prolonged lymphopenia although the role of lymphopenia in these cases is uncertain. Other serious side effects include a decrease in mean lymphocyte counts during the first year of treatment, herpes zoster and other serious infections, liver injury and flushing. In clinical trials, the most common adverse events associated with TECFIDERA were flushing, abdominal pain, diarrhea and nausea.
Please click here for Important Safety Information and full Prescribing Information, including Patient Information for TECFIDERA in the
About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by
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Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential benefits, safety and efficacy of TYSABRI (natalizumab), VUMERITY and Q6W; the results of the NOVA Phase 3b study, the results of the EVOLVE-MS-2 study and certain real-world data; clinical trials and data readouts and presentations; and the treatment of MS. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation uncertainty of success in the development and potential commercialization of Q6W; unexpected concerns that may arise from additional data, analysis or results obtained during the NOVA Phase 3b study, the EVOLVE-MS-2 study or other clinical studies of TYSABRI (natalizumab), VUMERITY and Q6W; the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of expansion of product labeling; risks of unexpected costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the
References:
- Chisari et al. Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2020;0:1–7. doi: 10.1136/jnnp-2020-323472.
- Butzkueven H et al. Similar Clinical Outcomes for Natalizumab Patients Switching to Every-6-Week Dosing Versus Remaining on Every-4-Week Dosing in Real-World Practice. Poster presented at 8th Joint ACTRIMS-ECTRIMS Virtual Meeting; September 11–13, 2020. P0393.
- Zhovtis Ryerson L et al. No Difference in Radiologic Outcomes for Natalizumab Patients on Extended Interval Dosing Compared with Standard Interval Dosing in MS PATHS. Poster presented at
American Academy of Neurology Virtual Annual Meeting; April 17-22,2021. P15.210. - Zhovtis Ryerson et al. Natalizumab Extended Interval Dosing (EID) is Associated with a Reduced Risk of Progressive Multifocal Leukoencephalopathy (PML) Compared with Every-4-week (Q4W) Dosing: Updated Analysis of the TOUCH® Prescribing Program Database. Poster presented at
American Academy of Neurology Virtual Annual Meeting;April 17-22 , 2021.P15.201 - Combined post-marketing data based on prescriptions and clinical trials exposure to TYSABRI as of
July 31, 2021 . - Combined post-marketing data based on prescriptions and clinical trials exposure to TECFIDERA as of
June 30, 2021 .
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