First treatment for schizophrenia to be administered four times a year
BEERSE, Belgium--(BUSINESS WIRE)--
Janssen-Cilag International NV announced today that the European
Commission (EC) has approved the use of TREVICTA® (paliperidone
palmitate a 3-monthly injection) for the maintenance treatment of
schizophrenia in adult patients. TREVICTA will provide the longest
dosing interval available for an antipsychotic medication in the
European Union, allowing patients to maintain an optimal level of
treatment in their blood with fewer administrations, compared to
currently available antipsychotic treatments. This may improve outcomes
for patients, carers and healthcare professionals.1,2
TREVICTA is indicated for the maintenance treatment of schizophrenia in
adult patients who are clinically stable on XEPLION®, a
1-monthly paliperidone palmitate product that was approved in 2011 for
the maintenance treatment of schizophrenia in the European Union.1
"This approval is a big step forward for people living with
schizophrenia," said Dr Andreas Schreiner, European Therapeutic Area
Leader, Neuroscience and Pain, Janssen. "With fewer administrations per
year compared to other approved treatments, TREVICTA can give people
with schizophrenia greater freedom to focus on other important aspects
of their life and less on their treatment. This new option has the
potential to reduce the likelihood of relapse and progression of the
disease. It also helps healthcare professionals ensure the person with
schizophrenia can benefit from continuous delivery of medication between
administrations."
The marketing authorisation for TREVICTA is based on two Phase 3
studies.2,3 The first was a randomised, multi-centre,
double-blind, placebo-controlled relapse prevention study in more than
500 patients with schizophrenia.3 The second was a
randomised, multi-centre, double-blind study comparing the efficacy and
safety of paliperidone palmitate 3-monthly and 1-monthly formulations.2
TREVICTA 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.1,2,3
The decision from the EC follows a Positive Opinion recommending the
approval of TREVICTA from the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) in April 2016.1
This approval allows for the marketing of TREVICTA in all 28 member
states of the European Union as well as the European Economic Area
countries (Norway, Iceland and Liechtenstein).
#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.4,5
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.6 The
symptoms of schizophrenia can include hallucinations, delusions, lack of
emotional response, social withdrawal/depression, apathy and a lack of
drive or initiative.4
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.7 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.7
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 the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives by finding
new and better ways to prevent, intercept, treat and cure disease
inspires us. We bring together the best minds and pursue the most
promising science. We are Janssen. We collaborate with the world for the
health of everyone in it. Learn more at www.janssen.com/EMEA.
Follow us at www.twitter.com/janssenEMEA.
Janssen-Cilag International NV is 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 a
newly approved 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 and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to: uncertainty of
commercial success; competition, including technological advances, new
products and patents attained by competitors; challenges to patents;
product efficacy or safety concerns resulting in product recalls or
regulatory action; manufacturing difficulties and delays; changes in
behavior and spending patterns or financial distress of purchasers of
health care products and services; 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. European Medicines Agency, Committee Medicinal Products for Human
Use. Summary of opinion: TREVICTA (paliperidone). 1 April 2016.
Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/004066/WC500204137.pdf
(last accessed May 2016).
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. 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.
4. American Psychiatric Association (APA). Practice guideline for the
treatment of patients with schizophrenia. Second edition 2004;42.
Available at http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/schizophrenia.pdf
(last accessed May 2016).
5. Picchioni MM et al. Schizophrenia. BMJ
2007;335(7610):91-5.
6. Lang U et al. Molecular mechanisms of schizophrenia. Cell
Physiol Biochem 2007;20:687.
7. 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 May 2016).
PHEM/PSY/0516/0003
PHGB/PSY/0516/0001
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