Janssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat
BEERSE, Belgium, October 15, 2013 /PRNewswire/ –
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
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)
and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count greater than or equal
to 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.
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
Please see full Summary of Product Characteristics for more details.
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)