CHMP Issues Positive Opinion Recommending Ofatumumab in Relapsing Multiple Sclerosis
January 29 2021 - 12:10PM
Company Announcement
- Novartis
receives positive CHMP opinion for subcutaneous ofatumumab for
adult patients with relapsing forms of multiple
sclerosis
- Opinion
based on Phase 3 ASCLEPIOS I and II studies
Copenhagen, Denmark; January 28, 2021 –
Genmab A/S (Nasdaq: GMAB) announced today that the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion and
recommended granting marketing authorization of subcutaneous
ofatumumab for the treatment of relapsing forms of multiple
sclerosis (RMS) in adults with active disease defined by clinical
or imaging features. Novartis submitted the Marketing
Authorization Application for ofatumumab in this indication in
January 2020. Ofatumumab is being developed and marketed worldwide
by Novartis under a license agreement between Genmab and Novartis
Pharma AG.
“The positive CHMP opinion for subcutaneous ofatumumab in
relapsing multiple sclerosis is an important step in potentially
bringing this product to patients in Europe who will benefit from
the efficacy and ease of dosing that ofatumumab will provide. We
look forward to the European Commission’s final decision on this
application,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab.
The opinion was based on data from the Phase 3 ASCLEPIOS I and
II trials, which investigated the efficacy and safety of monthly
subcutaneous ofatumumab 20mg versus once daily oral teriflunomide
14mg in adults with RMS. The results from the ASCLEPIOS studies
were presented at the 35th Congress of the European Committee for
Treatment and Research in Multiple Sclerosis (ECTRIMS) in September
2019 and published in the August 6, 2020 issue of The New England
Journal of Medicine.
About ASCLEPIOSThe ASCLEPIOS I and II studies
(NCT02792218 and NCT02792231) are twin, identical design, flexible
duration (up to 30 months), double-blind, randomized, multi-center
Phase 3 studies evaluating the safety and efficacy of ofatumumab
20mg monthly subcutaneous injections versus teriflunomide 14mg oral
tablets taken once daily in adults with a confirmed diagnosis of
RMS1,2. The two studies enrolled 1,882 patients with RMS, between
the ages of 18 and 55 years, with an Expanded Disability Status
Scale (EDSS) score between 0 and 5.51,2. The studies were conducted
in over 350 sites in 37 countries.
The primary endpoint of both studies was to demonstrate that
ofatumumab is superior to teriflunomide in reducing the frequency
of confirmed relapses as evaluated by the Annualized Relapse Rate
(ARR) in patients treated up to 30 months1,2. Secondary endpoints
included time to disability progression confirmed at three and six
months respectively, confirmed disability improvement at six
months, gadolinium enhancing T1 lesions, number of new or enlarging
T2 lesions, serum levels of neurofilament light chain (NfL), and
rate of brain volume loss1,2. Safety and the pharmacokinetic
properties of ofatumumab were also all measured throughout the
treatment period1,2.
About OfatumumabOfatumumab is a fully human
CD20 monoclonal antibody (mAb) self-administered by a once-monthly
subcutaneous injection in development for relapsing forms of
multiple sclerosis (RMS). It was approved in the U.S., as
Kesimpta®, for the treatment of RMS in adults, to include
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease, and is the first B-cell
therapy that can be self-administered at home by patients using a
Sensoready® pen. Initial loading doses of Kesimpta are given on
Days 1, 7 and 14, with the first injection performed under the
guidance of a healthcare provider. Ofatumumab works by binding to
the CD20 molecule on the B-cell surface and inducing potent B-cell
lysis and depletion. Ofatumumab is being developed and marketed
worldwide by Novartis under a license agreement between Genmab and
Novartis Pharma AG.
About Multiple SclerosisMultiple sclerosis (MS)
is a chronic inflammatory disease of the central nervous system
characterized by myelin destruction and axonal damage of the brain,
optic nerves and spinal cord3. MS disrupts the normal functioning
of the brain, optic nerves and spinal cord through inflammation and
tissue loss4. MS, which affects approximately 2.5 million people
worldwide5, is often characterized into the following forms:
primary progressive MS (PPMS) and relapsing forms of MS (RMS),
which includes relapsing-remitting MS (RRMS) and secondary
progressive MS (SPMS)6. Approximately 85% of patients initially
present with RMS7.
About GenmabGenmab is an international
biotechnology company with a core purpose to improve the lives of
patients with cancer. Founded in 1999, Genmab is the creator of
multiple approved antibody therapeutics that are marketed by its
partners. The company aims to create, develop and commercialize
differentiated therapies by leveraging next-generation antibody
technologies, expertise in antibody biology, translational research
and data sciences and strategic partnerships. To create novel
therapies, Genmab utilizes its next-generation antibody
technologies, which are the result of its collaborative company
culture and a deep passion for innovation. Genmab’s proprietary
pipeline consists of modified antibody candidates, including
bispecific T-cell engagers and next-generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug
conjugates. The company is headquartered in Copenhagen, Denmark
with locations in Utrecht, the Netherlands, Princeton, New Jersey,
U.S. and Tokyo, Japan. For more information, please visit
Genmab.com.
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations
& CommunicationsT: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, Head of Investor RelationsT: +45 3377 9558; E:
acn@genmab.com This Company Announcement contains forward looking
statements. The words “believe”, “expect”, “anticipate”, “intend”
and “plan” and similar expressions identify forward looking
statements. Actual results or performance may differ materially
from any future results or performance expressed or implied by such
statements. The important factors that could cause our actual
results or performance to differ materially include, among others,
risks associated with pre-clinical and clinical development of
products, uncertainties related to the outcome and conduct of
clinical trials including unforeseen safety issues, uncertainties
related to product manufacturing, the lack of market acceptance of
our products, our inability to manage growth, the competitive
environment in relation to our business area and markets, our
inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and
proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our
products or technologies obsolete, and other factors. For a further
discussion of these risks, please refer to the risk management
sections in Genmab’s most recent financial reports, which are
available on www.genmab.com and the risk factors included in
Genmab’s most recent Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission (SEC), which are
available at www.sec.gov. Genmab does not undertake any obligation
to update or revise forward looking statements in this Company
Announcement nor to confirm such statements to reflect subsequent
events or circumstances after the date made or in relation to
actual results, unless required by law. Genmab A/S and/or its
subsidiaries own the following trademarks: Genmab®; the Y-shaped
Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®;
HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®;
HexaBody®; HexaBody in combination with the HexaBody logo®;
DuoHexaBody®; HexElect®; and UniBody®. Kesimpta® and Sensoready®
are trademarks of Novartis AG or its affiliates.
1 ClinicalTrials.gov. Efficacy and Safety of Ofatumumab Compared
to Teriflunomide in Patients With Relapsing Multiple Sclerosis
(ASCLEPIOS I). https://clinicaltrials.gov/ct2/show/NCT02792218.
Accessed January 2020. 2 ClinicalTrials.gov. Efficacy and Safety of
Ofatumumab Compared to Teriflunomide in Patients With Relapsing
Multiple Sclerosis.(ASCLEPIOS II).
https://clinicaltrials.gov/ct2/show/NCT02792231. Accessed January
2020.3 Guthrie E. Multiple sclerosis: a primer and update.
Adv Studies Pharm. 2007;4(11):313-3174 John Hopkins Medicine.
Multiple sclerosis (MS).
https://www.hopkinsmedicine.org/neurology_neurosurgery/centers_clinics/multiple_sclerosis/conditions/index.html.
Accessed August 2019.5 GlobalData. EpiCast Report: Multiple
Sclerosis - Epidemiology Forecast to 2026. Published November
2017.6 Multiple sclerosis international federation. Types of MS.
https://www.msif.org/about-ms/types-of-ms/. Accessed August 20197
Datamonitor. Multiple Sclerosis Treatment. Published August
2016.
Company Announcement no. 07CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 280121_CA07_Ofa RMS CHMP opinion
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