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European Medicines Agency Validates Marketing Authorisation Application for ZINBRYTA™ (Daclizumab High-Yield Process) for Treatment of MS
Category:

Corporate, Neurology

Friday, March 27, 2015 7:00 am EDT

"The submission and validation of the MAA are important milestones for ZINBRYTA and mean this investigational treatment is one step closer to potentially becoming available to MS patients who may benefit from its novel profile"
CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--Today Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced that the European Medicines Agency (EMA) has validated the companies’ Marketing Authorisation Application (MAA) for ZINBRYTA™ (daclizumab high-yield process) for the treatment of relapsing forms of multiple sclerosis (MS) in the European Union (EU). Validation confirms that the submission is complete and signifies the initiation of the review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“The submission and validation of the MAA are important milestones for ZINBRYTA and mean this investigational treatment is one step closer to potentially becoming available to MS patients who may benefit from its novel profile,” said Gilmore O’Neill, vice president, Multiple Sclerosis Research and Development at Biogen.

The MAA included results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA 150 mg was administered subcutaneously every four weeks in people with relapsing-remitting MS.

“We are committed to bringing to market medicines that may provide remarkable impact for patients, and the EMA validation of the MAA for ZINBRYTA is an important step in accomplishing that mission for MS patients,” said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie.
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Source: press release, 3/27/15. http://media.biogen.com/press-release/corporate/european-medicines-agenc...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
ZINBRYTA (Daclizumab)NeurologyMultiple Sclerosis (MS) (RR)ImmunomodulatorIL-2R alpha receptor

Mechanism of action: ZINBRYTA (Daclizumab), a RhuMAb, decreases autoimmunity by prevention of T-cell activation via human monoclonal antibody to the IL-2R alpha receptor.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-04-01

Results:

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Biogen and AbbVie’s Once-Monthly ZINBRYTA™ (Daclizumab) Approved in European Union for Treatment of Multiple Sclerosis
- ZINBRYTA Significantly Reduced Multiple Measures of Disease Activity in Patients with Relapsing Forms of MS -

- Targeted Mechanism of Action of ZINBRYTA Did Not Cause Broad, Prolonged Depletion of Studied Immune Cell Types -

Category:
Collaborations, Corporate, Investor Relations, Neurodegenerative diseases
Tuesday, July 5, 2016 8:00 am EDT

"Clinical data showed ZINBRYTA significantly reduced relapses, 24-week confirmed disability progression and new brain lesions for up to three years compared to AVONEX® (interferon beta-1a) intramuscular injection, providing a valuable new option for people with RMS"
CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--The European Commission (EC) has granted marketing authorization for ZINBRYTA™ (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. ZINBRYTA is a once-monthly, self-administered, subcutaneous injection.

“Clinical data showed ZINBRYTA significantly reduced relapses, 24-week confirmed disability progression and new brain lesions for up to three years compared to AVONEX® (interferon beta-1a) intramuscular injection, providing a valuable new option for people with RMS,” said Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry. “ZINBRYTA has an immunomodulatory mechanism of action (MOA) that regulates inflammation without broadly depleting the immune system, and immune cell effects are reversible within six months. This offers an alternative approach to treating multiple sclerosis (MS) and is an important consideration when deciding how to sequence therapies throughout the course of a patient’s disease.”

The EC approval of ZINBRYTA is supported by results from two studies, including DECIDE, the largest and longest head-to-head Phase 3 study ever conducted in MS. The Phase 2b SELECT and Phase 3 DECIDE studies were global, randomized, double-blind, controlled studies that involved approximately 2,400 people living with RMS. Some patients in DECIDE were treated for up to three years.

In DECIDE and SELECT, ZINBRYTA significantly reduced patients’ annualized relapse rate (ARR), the primary endpoint of the studies, by 45 percent compared to AVONEX up to 144 weeks and by 54 percent compared to placebo at 52 weeks (both p<0.0001), respectively. Analyses of these studies demonstrated the consistent effect of ZINBRYTA relative to placebo and AVONEX across various subgroups of patients defined by demographic and MS disease characteristics.

“With the approval of ZINBRYTA in the European Union, we are providing a much needed treatment option for people living with MS,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “This is an important part of AbbVie’s ongoing commitment to advancing neuroscience research specifically in the area of MS.”

In addition to the statistically significant ARR, the Summary of Product Characteristics (SmPC) also includes the following ZINBRYTA clinical measures:

Statistically significant effect on 24-week confirmed disability progression in ZINBRYTA-treated patients with a hazard ratio of 0.73 [95% Confidence Interval 0.55, 0.98].
Statistically significant reduction in the number of new or newly enlarging T2 hyperintense lesions, the number of new T1 Gd-enhancing lesions and the mean number of new T1 hypointense lesions at 96 weeks.
Reduced clinically meaningful worsening in the patient-reported physical impact of MS (≥7.5 point worsening from baseline to week 96 in the MSIS-29 physical score) compared to AVONEX.
“ZINBRYTA is an important new once-monthly option for people with RMS, including those whose disease activity has been insufficiently controlled by their prior therapy,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “MS manifests differently in each person, with varied symptoms and progressions; therefore, it is important that people living with the disease have treatment choices to address their diverse and evolving needs.”

ZINBRYTA’s MOA is thought to block the activation of autoreactive T-cells, a major contributor to inflammation in the nervous system of people with MS. ZINBRYTA leads to an increase in immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells that contribute to the nerve injury caused by MS. These immunomodulatory effects of ZINBRYTA are believed to reduce central nervous system pathology in MS and thereby reduce the occurrence of relapse and disability progression.

During ZINBRYTA treatment, mean cell counts for the major immune subsets (T, B, and NK cells) remained within normal ranges; total lymphocyte, T and B cell counts decreased on average ≤10 percent from baseline during the first year of treatment.
Total lymphocyte counts returned to baseline within approximately eight to 12 weeks after the last dose, and all other cell counts studied returned to baseline within approximately 20 to 24 weeks after the last dose.
Warnings and precautions include hepatic injury, skin reactions, depression, infections, gastro intestinal disorders, and lymphopenia. The most commonly reported adverse reactions leading to discontinuation in patients treated with ZINBRYTA were hepatic reactions, including elevations of serum transaminases (5%), and cutaneous reactions (4%). The most common adverse events that occurred in ZINBRYTA-treated patients were rash, increased alanine aminotransferase (a type of liver enzyme), depression, nasopharyngitis (inflammation of the nose and part of the throat), upper respiratory tract infection, influenza, oropharyngeal (part of the throat) pain and lymphadenopathy (enlargement of the lymph nodes).
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Source: press release, 7/05/16. http://media.biogen.com/press-release/investor-relations/biogen-and-abbv...

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis
- Positive Benefit-Risk Profile of ZINBRYTA Supported by Large Head-to-Head Phase 3 DECIDE Study -

Category:
Corporate, Investor Relations, Neurodegenerative diseases
Friday, April 29, 2016 7:39 am EDT
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"For people with relapsing forms of MS (RMS) and active disease, ZINBRYTA has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing"
CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for ZINBRYTA™ (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. ZINBRYTA is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. ZINBRYTA is also currently under regulatory review in the United States, Switzerland, Canada and Australia.

“For people with relapsing forms of MS (RMS) and active disease, ZINBRYTA has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “ZINBRYTA may offer another option for people with multiple sclerosis (MS) with its targeted mechanism of action (MOA) which did not cause broad and prolonged immune cell depletion.”

The CHMP positive opinion is now referred to the European Commission (EC), which grants marketing authorizations for centrally authorized medicines in the European Union. A decision from the EC is expected within the coming months.

“Together with Biogen, AbbVie is committed to meeting the needs of patients with MS, and the positive opinion issued by the CHMP is a critical step that moves us closer to bringing ZINBRYTA to patients in Europe,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.

According to the CHMP opinion, the benefits of ZINBRYTA are its ability to reduce the annualized relapse rate (ARR), as well as the risk of 24-week confirmed disability progression. The opinion is based on results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA 150 mg, administered subcutaneously every four weeks improved results on key measures of MS disease activity in patients with RMS compared to AVONEX 30 mcg intramuscular injection administered weekly and placebo, respectively.

In the DECIDE study, the overall incidence of adverse events was similar in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA compared to AVONEX, there was an increased incidence of serious infections (4% versus 2%), serious cutaneous reactions (2% versus <1%), elevations of liver transaminases greater than five times the upper limit of normal (6% versus 3%), gastrointestinal disorders (31% versus 24%), and depression (8% versus 6%).
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Source: press release, 4/29/16. http://media.biogen.com/press-release/investor-relations/biogen-and-abbv...

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