FDA Advisory Committee Recommends Approval of Teva’s Asthma Biologic Reslizumab
10 Décembre 2015 - 2:00PM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today
that the U.S. Food and Drug Administration’s (FDA)
Pulmonary-Allergy Drugs Advisory Committee recommended approval of
reslizumab, a humanized anti-interleukin-5 (IL-5) IgG4K monoclonal
antibody (mAb), in adult patients aged 18 years and older.
Reslizumab is a targeted biologic therapy for the treatment of
inadequately controlled asthma in patients with elevated blood
eosinophils, despite an inhaled corticosteroid (ICS)-based
treatment regimen.
“Patient stratification based on eosinophil levels has been an
important advancement in the treatment of asthma,” said Michael
Hayden, M.D., Ph.D., President of Global R&D and Chief
Scientific Officer at Teva Pharmaceutical Industries Ltd. “We are
very encouraged by the outcome of today’s FDA Advisory Committee
meeting, which brings us one step closer to potentially providing a
new, targeted treatment option for a specific group of patients
with inadequately controlled asthma and evidence of ongoing
eosinophilic inflammation. This group of patients often experiences
persistent symptoms despite standard-of-care treatment,
demonstrating a need for more targeted treatment options based on
patient phenotype.”
The Advisory Committee's recommendation will be considered by
the FDA in its review of the Biologics License Application (BLA)
for reslizumab. The FDA is not bound by the Committee's
recommendation, but takes its advice into consideration when
reviewing investigational medicines. The reslizumab BLA was
accepted for standard review by the FDA and Regulatory Action is
expected in March 2016. Additional regulatory filings for
reslizumab have been completed in the EU and Canada.
About Reslizumab
Reslizumab is an investigational humanized interleukin-5 (IL-5)
antagonist IgG4K monoclonal antibody (mAb), for the treatment of
inadequately controlled asthma in adult and adolescent patients
with elevated blood eosinophils, despite an inhaled corticosteroid
(ICS)-based regimen. IL-5 is the most selective eosinophil cytokine
known and plays a major role in the maturation, activation and
survival of eosinophils, which are the predominant type of white
blood cell underlying chronic airway inflammation in the
eosinophilic phenotype of asthma. In asthma patients, elevated
blood eosinophils ≥400 cells/mcL are associated with compromised
lung function, persistent symptoms, and increased risk of
exacerbations. Reslizumab is thought to act by binding to and
neutralizing human IL-5 to reduce eosinophilic inflammation.
Reslizumab has been submitted for and is currently under review by
the U.S. Food and Drug Administration (FDA), European Medicines
Agency (EMA) and Health Canada.
About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment
options for respiratory conditions, including asthma, COPD and
allergic rhinitis. The Teva Respiratory portfolio is centered on
optimizing respiratory treatment for patients and healthcare
providers through the development of novel delivery systems and
therapies that help address unmet needs. The company’s respiratory
pipeline and clinical trial program are based on drug molecules
delivered in proprietary dry powder formulations and
breath-actuated device technologies, as well as a targeted biologic
treatment for inadequately controlled asthma. Through research
and clinical development, Teva Respiratory continually works to
expand, strengthen and build upon its treatment portfolio to
positively impact the lives of the millions of patients living with
respiratory disease.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,000
molecules to produce a wide range of generic products in nearly
every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to develop and commercialize
additional pharmaceutical products; competition for our specialty
products, especially Copaxone® (including competition from
orally-administered alternatives, as well as from generic
equivalents such as the recently launched Sandoz product) and our
ability to continue to migrate users to our 40 mg/mL version and
maintain patients on that version; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities (such as our pending acquisitions of Allergan’s
generic business and Rimsa), or to consummate and integrate
acquisitions; the possibility of material fines, penalties and
other sanctions and other adverse consequences arising out of our
ongoing FCPA investigations and related matters; our ability to
achieve expected results from the research and development efforts
invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; the extent to
which any manufacturing or quality control problems damage our
reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our
patent settlement agreements; our exposure to currency fluctuations
and restrictions as well as credit risks; the effectiveness of our
patents, confidentiality agreements and other measures to protect
the intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into sales and marketing practices, particularly for our specialty
pharmaceutical products; adverse effects of political or economic
instability, major hostilities or acts of terrorism on our
significant worldwide operations; interruptions in our supply chain
or problems with internal or third-party information technology
systems that adversely affect our complex manufacturing processes;
significant disruptions of our information technology systems or
breaches of our data security; competition for our generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; competition for our
specialty pharmaceutical businesses from companies with greater
resources and capabilities; the impact of continuing consolidation
of our distributors and customers; decreased opportunities to
obtain U.S. market exclusivity for significant new generic
products; potential liability in the U.S., Europe and other markets
for sales of generic products prior to a final resolution of
outstanding patent litigation; our potential exposure to product
liability claims that are not covered by insurance; any failure to
recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare
and Medicaid reporting and payment obligations; significant
impairment charges relating to intangible assets, goodwill and
property, plant and equipment; the effects of increased leverage
and our resulting reliance on access to the capital markets;
potentially significant increases in tax liabilities; the effect on
our overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our
Annual Report on Form 20-F for the year ended December 31, 2014 and
in our other filings with the U.S. Securities and Exchange
Commission.
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Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912Ran
Meir, 215-591-3033orIsraelTomer Amitai, 972
(3) 926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974Nancy
Leone, 215-284-0213
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