If approved, TREVICTA® will be the first
treatment for schizophrenia to be administered four times a year and
will provide the longest dosing interval available for an antipsychotic
medication in the European Union
BEERSE, Belgium--(BUSINESS WIRE)--
Janssen-Cilag International NV announced today that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a Positive Opinion recommending marketing
authorisation in the European Union for the medicinal product TREVICTA®
(paliperidone palmitate a 3-monthly injection) for the maintenance
treatment of schizophrenia. If approved, this 3-monthly injection will
allow patients to maintain an optimal level of treatment in their blood
with fewer administrations, compared to currently available
antipsychotic treatments, and therefore may improve outcomes for
patients, carers and HCPs.1 A 1-monthly formulation of
paliperidone palmitate (XEPLION®) is approved for the
maintenance treatment of schizophrenia in Europe.
"As paliperidone palmitate 3-monthly injection offers the opportunity
for fewer (only 4) injections per year, it has the potential to offer
eligible patients greater freedom and the opportunity to focus less on
taking their medication and more on getting and staying well." said Dr
Andreas Schreiner, European Therapeutic Area Leader, Neuroscience and
Pain, Janssen. "The extended dosing interval compared with current
treatments may also reduce the risk of relapse for a patient population
in whom adherence to antipsychotic medication can be a major factor in
the success of their treatment. We anticipate the EMA's final decision
in the coming months and hope that it will allow Janssen to provide
patients with a valuable new treatment option for schizophrenia."
The European filing of an Extension Marketing Authorisation Application
for paliperidone palmitate, a 3-monthly injection, is based on
two Phase 3 studies. The first was a randomised, multi-centre,
double-blind, placebo-controlled relapse prevention study in more than
500 patients with schizophrenia.1 The second study was a
randomised, double-blind clinical trial comparing the efficacy and
safety of paliperidone palmitate 3-monthly and 1-monthly formulations.2
Paliperidone palmitate 3-monthly injection was found to be at
least as effective in preventing relapse as the paliperidone palmitate
1-monthly formulation and was not associated with any new or unexpected
safety signals.2
As with all medications, some patients may experience side effects. The
most frequently observed adverse drug reactions reported in ≥ 5% of
patients in the two double-blind controlled clinical trials of
paliperidone palmitate 3-monthly injection were: increased weight, upper
respiratory tract infection, anxiety, headache, insomnia and injection
site reaction.1,2
Based on the CHMP's Positive Opinion, a final authorisation from the
European Commission is expected in the coming months. Paliperidone
palmitate 3-monthly injection is marketed as INVEGA TRINZA® in
the U.S. and receivedapproval from the Food and Drug
Administration (FDA) under Priority Review in May 2015.
#ENDS#
About schizophrenia
Schizophrenia is a complex and chronic brain disorder, in which symptoms
can be severe and disabling and can affect all aspects of a person's
daily life. It affects people from all countries, socio-economic groups
and cultures. Its prevalence is similar around the world - almost one
person in every 100 will develop schizophrenia before they reach the age
of 60, with men slightly more at risk.3,4
There is no single cause of schizophrenia. Different factors acting
together are thought to contribute to the development of the illness.
Both genetic and environmental factors seem to be important.5 The
symptoms of schizophrenia can include hallucinations, delusions, lack of
emotional response, social withdrawal/depression, apathy and a lack of
drive or initiative.
Schizophrenia is typically a lifelong condition but there are treatments
that can be beneficial. Clinical guidelines recommend that the optimal
treatment package is a combination of antipsychotic medication along
with psychotherapy, psycho-education and self-help.6 Effective
treatment may allow people with the condition to enjoy a more
fulfilling, well rounded life, which may include returning to work or
study, independent living and social relationships, which in turn can
aid their recovery.
For more information about schizophrenia, as well as helpful resources
and interactive tools for those affected by the condition, visit www.schizophrenia24x7.com.
This site is sponsored by Janssen Pharmaceutica NV.
About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated
to addressing and solving the most important unmet medical needs of our
time, including oncology (e.g., multiple myeloma and prostate cancer),
immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia,
dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and
tuberculosis), and cardiovascular and metabolic diseases (e.g.,
diabetes). Driven by our commitment to patients, we develop sustainable,
integrated healthcare solutions by working side-by-side with healthcare
stakeholders, based on partnerships of trust and transparency. More
information can be found on www.janssen.com/EMEA.
Follow us on www.twitter.com/janssenEMEA
for our latest news.
Cilag GmbH International; Janssen Biotech, Inc.; and Janssen-Cilag
International NV are part of the Janssen Pharmaceutical Companies of
Johnson & Johnson.
Cautions Concerning Forward-Looking
Statements
This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
product development, including potential regulatory approval of a new
product. The reader is cautioned not to rely on these forward-looking
statements. These statements are based on current expectations of future
events. If underlying assumptions prove inaccurate or known or unknown
risks or uncertainties materialize, actual results could vary materially
from the expectations and projections of Janssen-Cilag International NV,
any of the other Janssen Pharmaceutical Companies and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to:
challenges and uncertainties inherent in product development, including
the uncertainty of clinical success and of obtaining regulatory
approvals; uncertainty of commercial success; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; manufacturing difficulties or
delays; product efficacy or safety concerns resulting in product recalls
or regulatory action; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care cost
containment. A further list and description of these risks,
uncertainties and other factors can be found in Johnson & Johnson's
Annual Report on Form 10-K for the fiscal year ended January 3, 2016,
including in Exhibit 99 thereto, and the company's subsequent filings
with the Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov,
www.jnj.com
or on request from Johnson & Johnson. None of the Janssen
Pharmaceutical Companies or Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future
events or developments.
###
References
1. Berwaerts J et al. Efficacy and Safety of the 3-Month
Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention
of Schizophrenia: A Randomized Clinical Trial. JAMA Psych
2015;72(8):830-9.
2. Savitz A et al. Efficacy and safety of paliperidone palmitate
3-month formulation for patients with schizophrenia: A randomized,
multicenter, double-blind, non-inferiority study. Int J
Neuropsychopharmacol 2016 (Feb 22). doi: 10.1093 [Epub ahead of
print].
3. American Psychiatric Association (APA). Practice guideline for the
treatment of patients with schizophrenia. Second edition 2004;42.
4. Picchioni MM et al. Schizophrenia. BMJ
2007;335(7610):91-5.
5. Lang U et al. Molecular mechanisms of schizophrenia. Cell
Physiol Biochem 2007;20:687.
6. National Institute for Clinical Excellence: Psychosis and
schizophrenia in adults: prevention and management; National Clinical
Practice Guidelines Number CG178. Available at https://www.nice.org.uk/guidance/cg178
(last accessed April 2016).
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