Janssen Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination
Tablet of HIV-1 Medicine Darunavir with Cobicistat as Part of Combination HIV
RARITAN, N.J., April 1, 2014
RARITAN, N.J., April 1, 2014 /PRNewswire/ -- Janssen Research & Development,
LLC (Janssen), today announced it has submitted a New Drug Application (NDA)
to the U.S. Food and Drug Administration (FDA) seeking approval for a
once-daily fixed-dose antiretroviral combinationtablet containing darunavir,
a protease inhibitor developed by Janssen R&D Ireland and marketed as
PREZISTA^® in the U.S., with cobicistat, an investigational 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 PREZISTA^® is indicated for the treatment of HIV-1 in
treatment-naive and treatment-experienced adult patients with no darunavir
resistance-associated mutations. PREZISTA^® 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
additional therapeutic 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 tablet fixed-dose
combination product of darunavir and Gilead's cobicistat. Under the terms of
the agreement, Janssen R&D Ireland and its affiliates are responsible for the
formulation, manufacturing, registration, distribution and commercialization
of the darunavir and cobicistat fixed-dose combination worldwide. Gilead will
retain sole rights for the manufacture, development and commercialization of
cobicistat as a stand-alone product and for use in combination with other
"Darunavir is the most prescribed HIV protease inhibitor in the United
States^ and we are excited to be taking this important step in our efforts
to offer it with an alternative boosting agent in a fixed-dose combination
tablet," said Johan van Hoof, M.D., 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."
PREZISTA^® (darunavir) is a prescription medicine. It is one treatment option
in the class of HIV (human immunodeficiency virus) medicines known as protease
inhibitors. PREZISTA^® is always taken with and at the same time as ritonavir
(Norvir^®), in combination with other HIV medicines for the treatment of HIV
infection in adults. PREZISTA^® should also be taken with food.
oThe use of other medicines active against HIV in combination with
PREZISTA^®/ritonavir (Norvir^®) may increase your ability to fight HIV.
Your healthcare professional will work with you to find the right
combination of HIV medicines
oIt is important that you remain under the care of your healthcare
professional during treatment with PREZISTA^®
PREZISTA^® does not cure HIV infection or AIDS and you may continue to
experience illnesses associated with HIV-1 infection, including opportunistic
infections. You should remain under the care of a doctor when using
Please read Important Safety Information below, and talk to your healthcare
professional to learn if PREZISTA^® is right for you.
Important Safety Information
What is the most important information I should know about PREZISTA^®?
oPREZISTA^® can interact with other medicines and cause serious side
effects. See "Who should not take PREZISTA^®?"
oPREZISTA^® may cause liver problems. Some people taking PREZISTA^®,
together with Norvir^® (ritonavir), have developed liver problems which
may be life-threatening. Your healthcare professional should do blood
tests before and during your combination treatment with PREZISTA^®. If you
have chronic hepatitis B or C infection, your healthcare professional
should check your blood tests more often because you have an increased
chance of developing liver problems
oTell your healthcare professional if you have any of these signs and
symptoms of liver problems: dark (tea-colored) urine, yellowing of your
skin or whites of your eyes, pale-colored stools (bowel movements),
nausea, vomiting, pain or tenderness on your right side below your ribs,
or loss of appetite
oPREZISTA^® may cause a severe or life-threatening skin reaction or rash.
Sometimes these skin reactions and skin rashes can become severe and
require treatment in a hospital. You should call your healthcare
professional immediately if you develop a rash. However, stop taking
PREZISTA^® and ritonavir combination treatment and call your healthcare
professional immediately if you develop any skin changes with these
symptoms: fever, tiredness, muscle or joint pain, blisters or skin
lesions, mouth sores or ulcers, red or inflamed eyes, like"pink eye."
Rash occurred more often in patients taking PREZISTA^® and raltegravir
together than with either drug separately, but was generally mild
Who should not take PREZISTA^®?
oDo not take PREZISTA^® if you are taking the following medicines:
alfuzosin (Uroxatral^®), dihydroergotamine (D.H.E.45^®, Embolex^®,
Migranal^®), ergonovine, ergotamine (Cafergot^®, Ergomar^®),
methylergonovine, cisapride (Propulsid^®), pimozide (Orap^®), oral
midazolam, triazolam (Halcion^®), the herbal supplement St. John's wort
(Hypericum perforatum), lovastatin (Mevacor^®, Altoprev^®, Advicor^®),
simvastatin (Zocor^®, Simcor^®, Vytorin^®), rifampin (Rifadin^®,
Rifater^®, Rifamate^®, Rimactane^®), sildenafil (Revatio^®) when used to
treat pulmonary arterial hypertension, indinavir (Crixivan^®),
lopinavir/ritonavir (Kaletra^®), saquinavir (Invirase^®), boceprevir
(Victrelis™), or telaprevir (Incivek™)
oBefore taking PREZISTA^®, tell your healthcare professional if you are
taking sildenafil (Viagra^®, Revatio^®), vardenafil (Levitra^®, Staxyn^®),
tadalafil (Cialis^®, Adcirca^®), atorvastatin (Lipitor^®), rosuvastatin
(Crestor^®), pravastatin (Pravachol^®), or colchicine (Colcrys^®,
Col-Probenecid^®). Tell your healthcare professional if you are taking
estrogen-based contraceptives (birth control). PREZISTA^® might reduce the
effectiveness of estrogen-based contraceptives. You must take additional
precautions for birth control, such as condoms
This is not a complete list of medicines. Be sure to tell your healthcare
professional about all the medicines you are taking or plan to take, including
prescription and nonprescription medicines, vitamins, and herbal supplements.
What should I tell my doctor before I take PREZISTA^®?
oBefore taking PREZISTA^®, tell your healthcare professional if you have
any medical conditions, including liver problems (including hepatitis B or
C), allergy to sulfa medicines, diabetes, or hemophilia
oTell your healthcare professional if you are pregnant or planning to
become pregnant, or are breastfeeding
oThe effects of PREZISTA^® on pregnant women or their unborn babies
are not known. You and your healthcare professional will need to
decide if taking PREZISTA^® is right for you
oDo not breastfeed. It is not known if PREZISTA^® can be passed to
your baby in your breast milk and whether it could harm your baby.
Also, mothers with HIV should not breastfeed because HIV can be
passed to your baby in the breast milk
What are the possible side effects of PREZISTA^®?
oHigh blood sugar, diabetes or worsening of diabetes, and increased
bleeding in people with hemophilia have been reported in patients taking
protease inhibitor medicines, including PREZISTA^®
oChanges in body fat have been seen in some patients taking HIV medicines,
including PREZISTA^®. The cause and long-term health effects of these
conditions are not known at this time
oChanges in your immune system can happen when you start taking HIV
medicines. Your immune system may get stronger and begin to fight
infections that have been hidden
oThe most common side effects related to taking PREZISTA^® include
diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not
a complete list of all possible side effects. If you experience these or
other side effects, talk to your healthcare professional. Do not stop
taking PREZISTA^® or any other medicines without first talking to your
You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please refer to the ritonavir (Norvir^®) Product Information (PI and PPI) for
additional information on precautionary measures.
Please see full Prescribing Information for more details, available at
About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time 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 Research & Development, LLC is part of the
Janssen Pharmaceutical Companies of Johnson & Johnson. Please
visithttp://www.janssenrnd.comfor more information.
(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995 regarding product
development. 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 Research & Development, LLC, any of
the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks
and uncertainties include, but are not limited to: economic factors, such as
interest rate and currency exchange rate fluctuations; competition, including
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; general industry conditions including 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 Johnson & Johnson's Annual Report on Form 10-K
for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto,
and our subsequent filings with the Securities and Exchange Commission.
Copies of these filings are available online at www.sec.gov, www.jnj.comor 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.)
^ IMS Health. IMS National Prescription AuditTM. February 2014.
Phone: (609) 730-2823
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Phone: (732) 524-2524
Phone: (732) 524-6491
SOURCE Janssen Research & Development, LLC
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