Janssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with
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Janssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat
BEERSE, Belgium, Oct, 15. 2013 /PRN=KYODO JBN/ -
Janssen-Cilag International NV (Janssen), today announced it has submitted a
Marketing Authorisation Application to the European Medicines Agency seeking
approval for a once-daily single tablet fixed-dose antiretroviral combination
product containing darunavir, a protease inhibitor developed by Janssen, with
cobicistat, a pharmacokinetic enhancer or boosting agent, developed by Gilead
Sciences, Inc. (Gilead) for use in combination with other human
immunodeficiency virus (HIV-1) medicines.
Once-daily darunavir is marketed as PREZISTA(R) in the European Union.
PREZISTA(R) is always taken with and at the same time as ritonavir, a boosting
agent, with food and in combination with other HIV medicines. If approved, the
fixed-dose combination tablet will be marketed under a new brand name and will,
for the first time, offer an option that eliminates the need to take a boosting
agent in a separate tablet with once-daily darunavir.
In June 2011, Janssen announced a license agreement with Gilead for the
development and commercialization of a once-daily, single tablet fixed-dose
combination product of darunavir and Gilead's cobicistat. Under the terms of
the agreement, Janssen and its affiliates are responsible for the formulation,
manufacturing, registration, distribution and commercialization of the
darunavir and cobicistat fixed-dose combination worldwide. Gilead retains sole
rights for the manufacture, development and commercialization of cobicistat as
a stand-alone product and for use in combination with other agents.
"Over the last six years, Janssen has launched three therapies for people
living with HIV and is committed to further evaluating HIV therapies for a
broad range of patients. We are therefore excited to be applying for marketing
authorization for a single tablet combination product which includes darunavir,
the leading protease inhibitor worldwide, with an alternative boosting agent,"
said, Johan van Hoof, Therapeutic Area Head, Infectious Diseases and Vaccines,
Janssen. "This filing demonstrates our ongoing commitment to develop new HIV
treatment options and fixed-dose treatment regimens for those living with the
disease. The ultimate goal is to help all patients achieve an undetectable
viral load and a better quality of life."
About PREZISTA(R) (darunavir)
Darunavir, 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.
Since its initial approval in 2007, darunavir has also been indicated for
use in HIV-1 infected treatment-naive and treatment-experienced adult patients,
including those who have been highly pre-treated, in combination with ritonavir
and other ARTs. For treatment-experienced adult patients, the licensed dosing
for darunavir (DVR) is 600 mg taken with 100 mg ritonavir twice daily with food
or 800 mg taken with 100 mg ritonavir once daily with food for patients with no
DRV Resistance Associated Mutations (RAMs)[1] and who have plasma HIV-1 RNA
<100,000 copies/mL and CD4+ cell count >100 cells x 106/L. For
treatment-naive adult patients, the licensed dosing for darunavir is 800 mg
taken with 100 mg ritonavir once daily with food.
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1. V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V
Important Safety Information
In the registrational studies, darunavir was generally well tolerated. The
majority of the adverse reactions reported in patients who initiated therapy
with darunavir co-administered with 100 mg ritonavir were mild to moderate in
severity. The most frequent adverse reactions reported in clinical trials and
as spontaneous reports are diarrhoea, nausea, rash, headache and vomiting. The
most frequent serious reactions are acute renal failure, myocardial infarction,
immune reconstitution syndrome, thrombocytopenia, osteonecrosis, diarrhoea,
hepatitis and pyrexia. Please see the Summary of Product Characteristics for a
complete list of all possible side effects.
Before taking darunavir, patients should tell their doctor if they have any
medical conditions, including liver problems, including hepatitis B or C,
diabetes, symptoms of infections, change in body fat, haemophilia,
musculoskeletal problems, or allergy to sulfa medicines and should tell their
doctor if they are pregnant or planning to become pregnant, or are nursing.
Darunavir should not be used in patients allergic (hypersensitive) to it or
ritonavir or with severe liver problems.
Due to potential drug interactions, patients should talk to their healthcare
provider about all the medicines they are taking or plan to take, including
prescription and non-prescription medicines, vitamins, and herbal supplements.
Darunavir does not cure HIV infection or AIDS, and does not prevent passing
HIV to others.
Please see full Summary of Product Characteristics for more details.
About Janssen
At Janssen, we are dedicated to addressing some of the most important unmet
medical needs in oncology, immunology, neuroscience, infectious diseases and
vaccines, and cardiovascular and metabolic diseases. Driven by our commitment
to patients, we develop innovative products, services and healthcare solutions
to help people throughout the world. Janssen-Cilag International NV is part of
the Janssen Pharmaceutical Companies of Johnson & Johnson.
More information about Janssen can be found at http://www.janssen-emea.com.
(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. 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 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,
general industry conditions and competition; economic factors, such as interest
rate and currency exchange rate fluctuations; technological advances, new
products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approvals; challenges to
patents; changes in behavior and spending patterns or financial distress of
purchasers of health care products and services; changes to governmental laws
and regulations and domestic and foreign health care reforms; trends toward
health care cost containment; and increased scrutiny of the health care
industry by government agencies. A further list and description of these
risks, uncertainties and other factors can be found in Exhibit 99 of Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended December 30,
2012. Copies of this Form 10-K, as well as subsequent filings, are available
online at http://www.sec.gov, http://www.jnj.com or on request from Johnson &
Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson
undertake to update any forward-looking statements as a result of new
information or future events or developments.)
SOURCE: Janssen-Cilag International NV (Janssen)
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