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2015-03-30

Novartis International AG: Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload

Novartis International AG / Novartis announces FDA approval for JadenuTM to
simplify treatmentadministration for patients with chronic iron overload .
Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is
solely responsible for the content of this announcement.
* Jadenu (deferasirox), a new formulation of Exjade (deferasirox), is the
only once-daily oral tablet for iron chelation
* Jadenu, taken with or without food, simplifies daily treatment
administration for patients with chronic iron overload
* Chronic iron overload is a serious condition that can affect people with
sickle cell disease, thalassemia and myelodysplastic syndromes

Basel, March 30, 2015
-
Novartis announced today that the US Food and Drug Administration (FDA) has
approved JadenuTM(deferasirox) tablets, a new oral formulation of
Exjade®(deferasirox) tablets for oral suspension, for the treatment of
chronic iron overload due to blood transfusions in patients 2 years of age
and older, and chronic iron overload in non-transfusion-dependent thalassemia
syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only
once-daily oral iron chelator that can be swallowed whole.

Many patients with sickle cell disease, thalassemia or myelodysplastic
syndromes need repeated blood transfusions and consequently, long-term daily
chelation therapy. Jadenu oral tablets can be taken in a single step, with or
without a light meal, simplifying administration of treatment for chronic
iron overload. Exjade is a dispersible tablet that must be mixed in liquid
and taken on an empty stomach. Jadenu is approved under accelerated approval
based on a reduction of liver iron concentrations and serum ferritin levels.
Continued approval for this indication may be contingent upon verification
and description of clinical benefit in confirmatory trials.

"Novartis has had a long-term commitment to improving the lives of patients
with chronic iron overload," said Bruno Strigini, President, Novartis
Oncology. "Exjade transformed iron chelation therapy. We responded to
feedback from patients and their physicians, and now Jadenu, by simplifying
treatment administration, offers an important new option to help meet these
patients' needs."

Chronic iron overload is a life-threatening cumulative toxicity that results
from blood transfusions required to treat sickle cell disease,
myelodysplastic syndromes, thalassemia and other conditions. Chronic iron
overload also can occur in patients with NTDT due to increased iron
absorption in the stomach and intestines[1],[2]. If left untreated, chronic
iron overload can damage the liver and heart[3],[4].

Jadenu contains deferasirox, the same active ingredient that is in Exjade, a
medicine that has been used by patients with chronic iron overload for almost
10 years. Exjade currently is the most-prescribed chelator in the United
States[5].

"Jadenu is an exciting development for patients with chronic iron overload who
have been eager for alternative treatment options," said Dr. Elliott
Vichinsky, Director of Hematology and Oncology at the University of
California, San Francisco (UCSF) Benioff Children's Hospital Oakland and
Professor, UCSF School of Medicine. "Taking iron chelation therapy every day
has sometimes been a challenge for them. The administration of Jadenu oral
tablets once a day is simple."

Novartis has submitted additional regulatory applications for Jadenu in other
countries worldwide.

About Jadenu (deferasirox) Tablets for Oral Use

Jadenu is an iron chelator indicated for the treatment of chronically elevated
levels of iron in the blood caused by repeated blood transfusions
(transfusional hemosiderosis) in patients ages 2 years and older. Jadenu is
also indicated to treat patients ages 10 years and older who have chronic
iron overload resulting from a genetic blood disorder called
non-transfusion-dependent thalassemia (NTDT). These indications are approved
under accelerated approval based on a reduction of iron levels in the liver
(measured by liver iron concentration) and blood (measured by serum ferritin
levels). Continued approval for these indications may be contingent upon
verification and description of clinical benefit in confirmatory trials.
There are ongoing studies to find out how Jadenu works over a longer period
of time.

It is not known if Jadenu is safe or effective when taken with other iron
chelation therapy. Controlled clinical trials of deferasirox in patients with
myelodysplastic syndromes (a serious blood disorder) and chronic iron
overload due to blood transfusions have not been performed.

In the United States, Jadenu is available by prescription only.

Important Safety Information about Jadenu (deferasirox) Tablets for Oral Use

Jadenu contains deferasirox, the same active ingredient in Exjade
(deferasirox) tablets for oral suspension. Deferasirox may cause serious
kidney problems, liver problems, and bleeding in the stomach or intestines.
In some cases, these problems were fatal. Kidney problems occurred
particularly in patients with multiple medical conditions and those who were
very ill because of their disease. Bleeding in the stomach or intestines
occurred more often in elderly patients. Liver problems were more likely to
happen in patients older than 55 years.

Jadenu should not be taken by patients with pre-existing severe kidney and
liver problems; high-risk myelodysplastic syndromes; advanced cancer; low
platelet counts; or an allergy to Jadenu.

Since deferasirox has been on the market, there have been reports of serious
reactions, sometimes leading to death. Severe blood disorders (including
neutropenia, agranulocytosis, worsening anemia and thrombocytopenia), serious
allergic reactions (including swelling of the throat), severe skin reactions
(including Stevens Johnson syndrome and erythema multiforme), decreased
hearing and vision changes have been reported. These serious reactions and
deaths have happened most often when deferasirox was taken by elderly
patients. The most commonly reported side effects related to deferasirox in
clinical trials were nausea, vomiting, diarrhea, stomach pain, increases in
kidney laboratory values, and skin rash.

Please see full Prescribing Information including Boxed WARNING available
atwww.jadenu.com.

About Exjade (deferasirox) Tablets for Oral Suspension

Exjade is an iron chelator indicated for the treatment of chronically elevated
levels of iron in the blood caused by repeated blood transfusions
(transfusional hemosiderosis) in patients ages 2 years and older. Exjade is
also indicated to treat patients ages 10 years and older who have chronic
iron overload resulting from a genetic blood disorder called
non-transfusion-dependent thalassemia (NTDT). In patients Exjade lowered the
levels of iron in the blood (measured by serum ferritin levels) and liver
(measured by liver iron concentration). An improvement in survival or disease
symptoms resulting from reduction in elevated iron levels, however, has not
been proven.

It is not known if deferasirox is safe or effective when taken with other iron
chelation therapy. Controlled clinical trials of Exjade in patients with
myelodysplastic syndromes (a serious blood disorder) and chronic iron
overload due to blood transfusions have not been performed.

In the United States, Exjade is available by prescription only.

Important Safety Information about
Exjade (deferasirox) Tablets for Oral Suspension

Exjade may cause serious kidney problems, liver problems, and bleeding in the
stomach or intestines. In some cases, these problems were fatal. Kidney
problems occurred particularly in patients with multiple medical conditions
and those who were very ill because of their disease. Bleeding in the stomach
or intestines occurred more often in elderly patients. Liver problems were
more likely to happen in patients older than 55 years.

Exjade should not be taken by patients with pre-existing severe kidney and
liver problems; high-risk myelodysplastic syndromes; advanced cancer; low
platelet counts; or an allergy to Exjade.

Since Exjade has been on the market, there have been reports of serious
reactions, sometimes leading to death. Severe blood disorders (including
neutropenia, agranulocytosis, worsening anemia and thrombocytopenia), serious
allergic reactions (including swelling of the throat), severe skin reactions
(including Stevens Johnson syndrome and erythema multiforme), decreased
hearing and vision changes have been reported. These serious reactions and
deaths have happened most often when Exjade was taken by elderly patients.
The most commonly reported side effects related to Exjade in clinical trials
were nausea, vomiting, diarrhea, stomach pain, increases in kidney laboratory
values, and skin rash.

Please see full Prescribing Information including Boxed WARNING available
atwww.exjade.com.

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "long-term," "may be contingent," "commitment,"
"exciting," "ongoing," or similar terms, or by express or implied discussions
regarding potential marketing approvals for Jadenu, or regarding potential
future revenues from Jadenu or Exjade. You should not place undue reliance on
these statements. Such forward-looking statements are based on the current
beliefs and expectations of management regarding future events, and are
subject to significant known and unknown risks and uncertainties. Should one
or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
set forth in the forward-looking statements. There can be no guarantee that
Jadenu or Exjade will be submitted or approved for sale in any additional
markets, or at any particular time. Neither can there be any guarantee that
Jadenu or Exjade will be commercially successful in the future. In
particular, management's expectations regarding Jadenu and Exjade could be
affected by, among other things, unexpected regulatory actions or delays or
government regulation generally; the uncertainties inherent in research and
development, including unexpected clinical trial results and additional
analysis of existing clinical data; the company's ability to obtain or
maintain proprietary intellectual property protection; general economic and
industry conditions; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected manufacturing issues, and
other risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. 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 a...

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