OREANDA-NEWS. September 13, 2016. Janssen-Cilag International NV (Janssen) today announced the submission
of a Marketing Authorisation Application to the European Medicines
Agency (EMA), seeking approval for a new once-daily darunavir-based
single tablet regimen (STR). If approved, this tablet would be the first
protease inhibitor (PI)-based STR option (D/C/F/TAF FDC), indicated as a
complete regimen for the treatment of human immunodeficiency virus
type 1 (HIV-1) infection in adults and adolescents (aged 12 years and
older with body weight of at least 40 kg). This new treatment would
combine the protease inhibitor, darunavir (DRV, D, 800 mg), with the
pharmacokinetic enhancer, cobicistat (COBI, C, 150 mg) and the
nucleoside reverse transcriptase inhibitors emtricitabine (FTC, F, 200
mg) and tenofovir alafenamide (TAF 10 mg), in one single tablet.
Treatment regimens that combine DRV/COBI (REZOLSTA®,Janssen-CilagInternational NV) and F/TAF (Gilead Sciences International Ltd)
are currently approved1,2 for the maintenance treatment of
HIV. The darunavir STR option is a significant evolution of this
approach, combining both treatments in a single, convenient tablet.
"Darunavir is an extensively used HIV protease inhibitor in the
European Union. We are excited to take this important step in our
efforts to offer simpler solutions for people living with HIV," said
Lawrence M. Blatt, Ph.D., global therapeutic area head, Janssen
Infectious Diseases and Vaccines, and president and chief executive
officer of Alios BioPharma, Inc. "Progress in the development of
effective treatments is helping people with HIV to live longer, but
treatment regimens can still impact daily life. Eliminating the need for
separate tablets will not only be convenient for people living with HIV
but is likely to lead to improved treatment adherence."
On 29 December 2014, Janssen announced a license agreement with Gilead
for the development and commercialisation of a once daily STR
combination of darunavir and Gilead's cobicistat, emtricitabine and
tenofovir alafenamide. Under the terms of the agreement, Janssen and its
affiliates are responsible for the manufacturing, registration,
distribution and commercialisation of this STR worldwide. Gilead retains
sole rights for the manufacturing, development and commercialisation of
cobicistat, emtricitabine and tenofovir alafenamide as stand-alone
products, and for use in combination with other agents.
About HIV
Since the beginning of the HIV epidemic, almost 70 million people
worldwide have been infected with the HIV virus.3 It is
estimated that 36.7 million people are currently living with HIV
globally.3 HIV transmission is a major concern in Europe, in
particular in the eastern part of the WHO European Region. In 2014, more
than 142,000 people were diagnosed with HIV - the highest number of
newly diagnosed infections ever reported in one year.4
Of these, 77% were diagnosed in the East of the Region and 21% in the
EU/EEA.4
More data on HIV is available at the DiseaseLens™ platform which
aggregates, besides 19 other diseases, the HIV disease burden public
data in one place and allows to compare them among 31 countries in
Europe and Israel: http://www.diseaselens.com/v2/disease.php?disease=5
- https://www.youtube.com/watch?v=PtzR8TfoKfk"
About PREZISTA® (darunavir)
PREZISTA, co-administered with low dose ritonavir is indicated in
combination with other antiretroviral medicinal products for the
treatment of human immunodeficiency virus (HIV-1) infection in adult and
paediatric patients from the age of 3 years and at least 15 kg body
weight.
PREZISTA, co-administered with cobicistat is indicated in combination
with other antiretroviral medicinal products for the treatment of human
immunodeficiency virus (HIV-1) infection in adult patients.
In deciding to initiate treatment with PREZISTA co-administered with
cobicistat or low dose ritonavir, careful consideration should be given
to the treatment history of the individual patient and the patterns of
mutations associated with different agents. Genotypic or phenotypic
testing (when available) and treatment history should guide the use of
PREZISTA.
About REZOLSTA® (darunavir/cobicistat)
REZOLSTA is an antiviral medicine used, in combination with other
medicines, to treat adults with human immunodeficiency virus type 1
(HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
REZOLSTA contains the active substances darunavir and cobicistat. The
medicine is for use only in patients who have not received HIV treatment
before or previously treated patients whose disease is not expected to
be resistant to darunavir and who are healthy enough and have HIV virus
levels below a certain threshold.
About Janssen in HIV
Janssen is committed to research and development of medicines to treat
HIV infections; combat resistance; simplify treatment; and discover,
develop, and conduct early basic research toward fulfilling the dream of
a preventative HIV vaccine.
About the Janssen Pharmaceutical Companies of Johnson and Johnson
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 http://www.janssen.com/emea.
Follow us at www.twitter.com/janssenEMEA.
Cautions Concerning Forward-Looking
Statements
This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
development of treatment options for HIV-1. 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: challenges and
uncertainties inherent in product development, including uncertainty of
clinical success and obtaining regulatory approvals; competition,
including technological advances, new products and patents attained by
competitors; challenges to patents; 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 most recent Annual Report on Form 10-K, 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.
September 2016
References
1. European Medicines Agency:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002819/human_med_001817.jsp&mid=WC0b01ac058001d124
Last accessed September 2016.
2. European Medicines Agency:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004094/human_med_001978.jsp&mid=WC0b01ac058001d124
Last accessed September 2016.
3. World Health Organization. Global Health Observatory (GHO). HIV/AIDS.
Available
at: http://www.who.int/gho/hiv/en/
Last accessed September 2016.
4. ECDC-WHO Report HIV/AIDS Surveillance in Europe 2014. Available at: http://www.euro.who.int/en/health-topics/communicable-diseases/hivaids/publications/2015/ecdc-who-report-hivaids-surveillance-in-europe-2014
Last accessed September 2016.
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