�Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. (J&JPRD) announced that the U.S. Food
and Drug Administration (FDA) requires extra information before it
will approve the company's New Drug Application (NDA) for DORIBAX(TM)
(doripenem for shot) for the treatment of hospital-acquired pneumonia,
also known as nosocomial pneumonia (NP), including ventilator-associated
pneumonia (VAP).
In response to the J&JPRD lotion seeking approval for DORIBAX for
the additional indication of the treatment of NP, including VAP, the FDA
issued a Complete Response varsity letter outlining the actions necessary to
address outstanding issues.
J&JPRD is reviewing the agency's letter and volition work to resolve whatever
outstanding questions. The NDA for DORIBAX for the treatment of NP,
including VAP, was submitted to the FDA in June 2007.
The NDA for DORIBAX for the handling of NP, including VAP, was the
subject of a July 16, 2008 U.S. Food and Drug Administration Anti-Infective
Drugs Advisory Committee. Based on information presented from two turgid nosocomial
pneumonia trials, the committee voted that five hundred mg of DORIBAX at both the
one-hour and four-hour extract regimens were safe (85) and effective
(7-6) in the treatment of NP, including VAP. The committee did non agree
that the non-inferiority margin for the DORIBAX NP trials was befittingly
justified, nor did it agree on the appropriate margin for NP trials in
general. J&JPRD is confident in the NP data submitted and will work with
the FDA to address the issues raised in the Complete Response letter.
DORIBAX is an endovenous (IV) antibiotic drug for hospital use, and belongs
to a class of antibacterial drug drugs called carbapenems. Carbapenems are
of import antibiotics to treat serious -- and sometimes grave --
infections caused by a broad range of bacteria, which are characterized as
Gram-negative and Gram-positive, based on a categorization process that is
used to identify the specific type of bacteria.
DORIBAX was approved in the U.S. in October 2007 for the treatment of
complicated intra-abdominal infections (cIAI) and complicated urinary tract
infections (cUTI), including pyelonephritis, due to susceptible bacteria,
and is marketed by Ortho-McNeil, Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc. DORIBAX besides is approved in Europe and Russia for
cIAI, cUTI and NP, including VAP. Doripenem is licenced from Shionogi &
Co., Ltd.
INDICATIONS
DORIBAX is indicated as a single federal agent for the treatment of:
complicated intra-abdominal infections caused by susceptible strains of E.
coli, K. pneumoniae, P. aeruginosa, B. caccae, B. fragilis, B.
thetaiotaomicron, B. uniformis, B. vulgatus, S. intermedius, S.
constellatus or P. micros, and for the treatment of complicated urinary
tract infections, including pyelonephritis, caused by susceptible strains
of E. coli, including cases with concurrent bacteriaemia, K. pneumoniae, P.
mirabilis, P. aeruginosa, or A. baumannii.
To reduce the development of drug-resistant bacterium and keep the
strength of DORIBAX and other antibacterial drugs, DORIBAX should be
ill-used only to treat infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibleness information
ar available, they should be considered in selecting and modifying
bactericide therapy. In the absence of such data, local epidemiology and
susceptibility patterns may put up to the empiric choice of therapy.
IMPORTANT SAFETY INFORMATION
DORIBAX is contraindicated in patients with known life-threatening
hypersensitivity to doripenem or other carbapenems or in patients world Health Organization have
demonstrated anaphylactic reactions to beta-lactams.
Serious and occasionally fateful hypersensitivity (anaphylactic) and
serious skin reactions have been reported in patients receiving beta-lactam
antibiotics. These reactions are more likely to occur in individuals with a
history of sensitivity to multiple allergens. If an hypersensitized reaction to
DORIBAX occurs, discontinue the drug. Serious acute anaphylactic reactions
require emergency discourse with adrenaline and other emergency measures,
including atomic number 8, IV fluids, IV antihistamines, corticosteroids, vasoconstrictor
amines and airway management, as clinically indicated.
Carbapenems may reduce serum valproic acid concentrations to
subtherapeutic levels, resulting in loss of capture control. Serum valproic
acidulous concentrations should be monitored frequently after initiating
carbapenem therapy. Alternative antibacterial or anticonvulsant therapy
should be considered if serum valproic acid concentrations cannot be
maintained in the remedial range or seizures occur.
Clostridium difficile-associated diarrhea (CDAD) has been reported with
use of nearly all antibacterial agents and may range in severity from mild
diarrhoea to fatal colitis. CDAD must be considered in all patients who
introduce with diarrhoea following antibiotic drug use. Careful medical history is
necessary since CDAD has been reported to occur o'er two (2) months after
administration of antibacterial agents. If CDAD is suspected or confirmed,
ongoing antibiotic use not directed against C. difficile may need to be
discontinued.
When DORIBAX has been used investigationally via inhalation,
pneumonitis has occurred. DORIBAX should not be administered by this route.
Safety and effectiveness in pediatric patients have non been
established.
The to the highest degree common adverse reactions (greater than or equal to 5%)
discovered in clinical trials were headache, nausea, diarrhea, efflorescence and
phlebitis.
Please see the DORIBAX Full Prescribing Information by visiting
http://www.DORIBAX.com
Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.,
is committed to providing innovative, superiority prescription medicines
and resources in the areas of bacterial contagion and cardiovascular
disease for healthcare providers and their patients in hospitals and other
care facilities. For more information, visit hypertext transfer protocol://www.ortho-mcneil.com.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is
part of Johnson & Johnson, the world's most broadly based producer of
healthcare products. J&JPRD is headquartered in Raritan, NJ, and has
facilities throughout Asia, Europe and the U.S. J&JPRD is leveraging drug
discovery and do drugs development in a assortment of sanative areas to address
unmet medical of necessity worldwide.
FORWARD LOOKING STATEMENT
(This press release contains "innovative statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If fundamental assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from the Company's expectations and
projections. Risks and uncertainties let in general industry conditions
and competition; economic conditions, such as interest rate and currency
exchange rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms
and governmental laws and regulations; and trends toward wellness care cost
containment. further list and description of these risks, uncertainties
and other factors can be plant in Exhibit 99 of Johnson & Johnson's Annual
Report on Form 10-K for the fiscal year ended December 30, 2007. 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. The Company
does not undertake to update any forwards looking statements as a result of
new information or future events or developments.)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
http://www.jnj.com
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