FDA approves Novartis TOBI® Podhaler™ for certain cystic fibrosis patients,
the first and only dry powder inhaled antibacterial in US
- TOBI Podhaler is portable and requires no nebulizer, refrigeration or power
source to deliver the medicine
- TOBI Podhaler is indicated for certain cystic fibrosis (CF) patients with Pa
and shortens treatment time by about 70% compared to nebulized TOBI®
- CF affects about 30,000 children and adults in the US with an average daily
treatment burden of approximately 2 hours for CF therapies
EAST HANOVER, N.J., March 22, 2013
EAST HANOVER, N.J., March 22, 2013 /PRNewswire/ -- Novartis announced today
that the US Food and Drug Administration (FDA) has approved TOBI^® Podhaler™
(tobramycin inhalation powder) 28 mg per capsule for the management of cystic
fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) bacteria in the lungs.
Pa is the leading cause of loss of lung function in CF patients. It is not
known if TOBI Podhaler is safe and effective in patients under six years of
age, in those with lung function outside of a certain range, or in those whose
lungs contain bacteria called Burkholderia cepacia.
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TOBI Podhaler is a new, non-nebulized formulation and delivery system of
tobramycin, the same active ingredient as in TOBI^® (tobramycin inhalation
solution, USP) 300 mg/5 mL, which has been on the market for approximately 15
years. TOBI Podhaler is the first and only FDA-approved dry powder inhaled
antibacterial for Pa in the US. It delivers tobramycin into the patient's
lungs via a pocket-sized dry powder inhaler and offers better portability than
TOBI, which is administered using a nebulizer. In a Phase III study, TOBI
Podhaler shortened administration time for patients by approximately 70%
compared to TOBI, saving about 13 hours per treatment cycle. This does not
include the time saved on setting up and maintaining the nebulizer and
TOBI Podhaler does not need to be stored in a refrigerator and, unlike
nebulized Pa treatments, does not require a power source to operate the
delivery device. While the nebulizer used to administer TOBI must be
disinfected in boiling water for 10 minutes every other treatment day, the
disposable Podhaler device must only be wiped clean with a dry cloth after
each use and is then replaced weekly.
"This is good news for the CF community," said Robert J. Beall, Ph.D.,
President and CEO, Cystic Fibrosis Foundation. "Managing daily CF treatments
is a challenge for people with CF. TOBI Podhaler helps relieve that burden by
shortening the time it takes to administer the medicine and making it easy for
people with CF to take their treatment with them wherever they need to go."
The new TOBI Podhaler dry powder formulation was developed using proprietary
Novartis PulmoSphere™ technology. This technology enables the creation of
hollow porous particles of tobramycin that can be delivered as a dry powder
rather than as a nebulized solution.
"TOBI Podhaler is an example of how Novartis is utilizing innovative
technologies to better meet the needs of patients. By eliminating the need
for a nebulizer to deliver tobramycin and providing a small, lightweight
design, TOBI Podhaler reduces administration time and improves portability for
patients on-the-go," said Andre Wyss, President of Novartis Pharmaceuticals
Corporation. "It also underscores our long-term commitment to the cystic
TOBI Podhaler was studied in a Phase III clinical program involving 674 CF
patients aged six years and older with Pa in their lungs, of whom 425 patients
received at least one dose of TOBI Podhaler. Two trials evaluated the efficacy
of TOBI Podhaler vs. placebo, while a third trial assessed the safety of TOBI
Podhaler vs. TOBI. All studies evaluated TOBI Podhaler at the approved dose
of 112 mg twice daily (the contents of four 28 mg capsules per dose) in cycles
of 28 days on, immediately followed by 28 days off treatment. Results of the
efficacy studies showed that TOBI Podhaler improved lung function compared to
The safety of TOBI Podhaler was evaluated in 425 patients who received at
least one dose of TOBI Podhaler, including 273 who were exposed across three
cycles. In the two placebo-controlled efficacy trials, adverse reactions
reported more commonly with TOBI Podhaler compared to placebo included
pharyngolaryngeal pain (sore throat), dysphonia (voice alteration) and
dysgeusia (taste disturbance) in one study and cough and hypoacusis (decreased
hearing) in the other study. In the safety study, the most commonly reported
adverse reactions (as defined as >10% in either treatment arm) with TOBI
Podhaler were cough, lung disorder (pulmonary or CF exacerbations), productive
cough, dyspnea (shortness of breath), pyrexia (fever), oropharyngeal pain
(sore throat), dysphonia (voice alteration), hemoptysis (coughing up blood)
CF is a life-shortening genetic disease that affects about 30,000 children and
adults in the US. It primarily impacts the lungs and digestive system, making
it hard to breathe and to digest food. Pa is the leading cause of loss of lung
function in people with CF. About 80% of people with CF between the ages of
25 and 34 have Pa in their lungs.
The treatment burden for CF is very high. CF therapy requires multiple
medications to be used every day with a combined average treatment time of 108
minutes per day.
TOBI Podhaler is anticipated to be available in the US in the second quarter
of 2013. Please visit
http://www.pharma.us.novartis.com/product/pi/pdf/tobipodhaler.pdf for TOBI
Podhaler full Prescribing Information.
TOBI^® (tobramycin inhalation solution, USP) 300 mg/5 mL, is a prescription
inhaled medication for cystic fibrosis patients whose lungs contain bacteria
called Pseudomonas aeruginosa. TOBI has not been studied in patients under six
years of age, in those with lung function (FEV) outside of a certain range,
or in those whose lungs contain bacteria called Burkholderia cepacia.
IMPORTANT SAFETY INFORMATION
If patients are allergic to antibiotics in the same family as TOBI (i.e.,
aminoglycosides), they should not take TOBI. They should tell their doctor
before starting treatment if they have any history of hearing, kidney,
balance, or muscle problems.
Patients taking TOBI may have temporary side effects like coughing or
difficulty breathing. Some people taking TOBI experienced ringing in the ears,
hearing loss, or changes in voice (hoarseness). Ringing in the ears may be a
warning sign for hearing loss. If patients have ringing in the ears, changes
in hearing, or dizziness, they should tell their doctor.
In studies, kidney damage was not seen in patients taking TOBI. However,
antibiotics in the same family as TOBI have been linked to kidney damage.
If patients are pregnant, plan to become pregnant, or if they are
breast-feeding, they should talk with their doctor before taking TOBI.
Some drugs may interact with TOBI. Patients should discuss all medications
they are taking with their doctor.
Patients with cystic fibrosis can have many symptoms. Some of these may be
related to their medications. They should tell their doctor if they have new
or worsening symptoms.
Patients 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 visit www.pharma.us.novartis.com/product/pi/pdf/tobi.pdf for TOBI full
For more information about cystic fibrosis, please visit www.cff.org.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "long-term commitment," "anticipated," or
similar expressions, or by express or implied discussions regarding potential
future revenues from TOBI Podhaler. You should not place undue reliance on
these statements. Such forward-looking statements reflect the current views of
management regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that TOBI Podhaler will
achieve any particular levels of revenue. In particular, management's
expectations could be affected by, among other things, unexpected clinical
trial results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; unexpected regulatory actions
or delays or government regulation generally; competition in general;
government, industry and general public pricing pressures, and unexpected
reimbursement decisions; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; unexpected manufacturing
issues; the impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as recorded in the
Group's consolidated balance sheet, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. Novartis
is providing the information in this press release as of this date and does
not undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information, future events
Novartis Pharmaceuticals Corporation researches, develops, manufactures and
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