Novartis drug Jakavi® first medication to receive European Commission approval to treat patients with myelofibrosis
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Novartis drug Jakavi® first medication to receive European Commission approval
to treat patients with myelofibrosis
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* Jakavi(®) (INC424, ruxolitinib) approval based on results from the most
extensive myelofibrosis clinical trial program to date
* Myelofibrosis is a life-threatening blood cancer associated with
progressive, debilitating symptoms that can severely impact quality of life
and shorten survival
* In Phase III studies, Jakavi reduced spleen size and debilitating
manifestations of myelofibrosis by targeting the underlying mechanism of
disease
Basel, August 28, 2012 - Novartis received approval today from the European
Commission for Jakavi(®) (INC424, ruxolitinib), a JAK 1 and JAK 2 inhibitor for
the treatment of disease-related splenomegaly or symptoms in adult patients with
primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-
polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
The European Commission's decision was based on positive findings from the
COMFORT (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy)
clinical trial program.
"The approval of Jakavi by the European Commission brings an urgently needed new
treatment option with the potential to make a real difference in patients'
lives," said Dr. Claire Harrison, MD, Guy's and St. Thomas' NHS Foundation
Trust, Guy's Hospital, London. "By targeting the dysregulated JAK pathway,
Jakavi delivers a rapid and durable benefit that has the potential to become a
new standard of care."
Myelofibrosis is an uncommon, life-threatening blood cancer characterized by
bone marrow failure, enlarged spleen (splenomegaly), debilitating symptoms, such
as extreme fatigue, night sweats and intractable pruritus (itching), poor
quality of life and weight loss, as well as shortened survival[1]. In the EU,
the disease affects about 0.75 out of every 100,000 people annually[2],[3].
Myelofibrosis develops when uncontrolled signaling in the JAK pathway - which
regulates blood cell production - causes bone marrow scarring and faulty blood
cell production, resulting in an enlarged spleen and other severe complications.
Jakavi directly targets the underlying mechanism of disease, significantly
reducing splenomegaly and improving symptoms regardless of JAK mutational
status, disease subtype or any prior treatment, including hydroxyurea[4],[5].
"This approval marks a significant milestone in addressing unmet treatment needs
for patients in the European Union," said Hervé Hoppenot, President, Novartis
Oncology. "We are committed to the development of innovative treatments for
orphan diseases, and are furthering research to assess the potential of targeted
Jakavi therapy for other malignancies associated with a dysregulated JAK
pathway."
The efficacy and safety of Jakavi in the treatment of patients with
myelofibrosis was established in clinical studies, including the two pivotal
Phase III trials - COMFORT-I and COMFORT-II. Chronic inflammation through
elevated cytokine levels is one of the primary consequences of dysregulated JAK
1 and JAK 2 signaling, and may be a major contributor to morbidity and mortality
of patients with myeloproliferative neoplasms such as myelofibrosis[6]. In one
pivotal Phase III study, Jakavi was shown to alter the clinical course of
myelofibrosis by reversing symptom progression and splenomegaly, thus improving
quality of life and potentially impacting overall survival[4],[5].
COMFORT-I demonstrated that 41.9% of Jakavi-treated patients achieved at least a
35% reduction (roughly equivalent to a reduction in palpable spleen size by
50%) in spleen volume at 24 weeks from baseline compared to 0.7% of patients in
the placebo group (p<0.001). An early analysis of COMFORT-I data at 51 weeks of
treatment showed Jakavi treatment resulted in an overall survival benefit as
compared to placebo (hazard ratio=0.50 [95% confidence interval:
0.25, 0.98])[5].
The most frequently reported grade 3 or higher adverse events were hematologic.
One patient in each group discontinued treatment for thrombocytopenia or for
anemia, respectively. The most common non-hematologic adverse events of any
grade reported for patients receiving Jakavi or placebo, respectively, were
fatigue (25% vs 34%), diarrhea (23% vs 21%), peripheral edema (19% vs 22%) and
ecchymosis (19% vs 9%). One week after discontinuing Jakavi, these patients
experienced a return of myelofibrosis symptoms that were present before
initiating therapy; however, any symptoms they experienced as a result of
treatment discontinuation subsided[5]. COMFORT-I was conducted in the US by
Incyte under the worldwide collaboration and license agreement for INC424
(ruxolitinib).
In COMFORT-II, Jakavi produced a volumetric spleen size reduction of 35% or
greater in 28% of patients compared to 0% of patients in the best available
therapy (BAT) group at 48 weeks (p<0.001). The BAT is any commercially available
agent (such as monotherapy or in combination) or no therapy at all. At week
24, 32% of patients treated with Jakavi demonstrated a 35% or greater volumetric
spleen size reduction compared to 0% of patients treated with the BAT (p<0.001)
for the key secondary endpoint. Additionally, Jakavi was associated with
improvements in myelofibrosis symptoms at each evaluation as compared with the
BAT group. Jakavi showed modest toxicity as compared with the BAT, with
increased frequency of anemia and thrombocytopenia. The most frequently reported
serious adverse event (SAE) was anemia for both groups (INC424, 5%; BAT, 4%).
Pneumonia was the only SAE reported in ≥5% of patients in either group
(INC424, 1%; BAT, 5%)[4]. These findings are consistent with previous
investigation of INC424[7]. ( )
Continuous Jakavi therapy also provided a marked and durable improvement in
overall quality of life measures, functioning and symptoms, including loss of
appetite, dyspnea (shortness of breath), fatigue, insomnia and pain, at week
48, compared to a worsening of symptoms in BAT-treated patients. Jakavi showed
modest toxicity as compared with the BAT, with increased frequency of anemia and
thrombocytopenia. The most frequently reported SAE for Jakavi was anemia for
both groups (5%). Pneumonia was reported in 1% of patients taking Jakavi[4].
About Myelofibrosis
Myelofibrosis is a life-threatening blood cancer with a poor prognosis and
limited treatment options[1],[7]. Studies show that patients with myelofibrosis
have a decreased life expectancy, with a median survival of 5.7 years[8].
Although allogeneic stem cell transplantation may cure myelofibrosis, the
procedure is associated with significant morbidity and transplant-related
mortalityand is available to less than 5% of patients who are young and fit
enough to undergo the procedure[9].
About Jakavi
Jakavi(®) (INC424, ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2
tyrosine kinases[4]. The recommended starting dose for Jakavi is 15 mg twice
daily for patients with a platelet count between 100,000cubic millimeters
(mm(3)) and 200,000 mm(3),and 20 mg twice daily for patients with a platelet
count of >200,000 mm(3). Doses may be titrated based on safety and efficacy.
Novartis licensed INC424 (ruxolitinib) from Incyte for development and potential
commercialization outside the US. Incyte has retained rights for the development
and commercialization of INC424 (ruxolitinib) in the US. Both the European
Commission and the US Food and Drug Administration (FDA) granted INC424
(ruxolitinib) orphan drug status for myelofibrosis. Incyte received FDA approval
for INC424 (ruxolitinib) in November 2011 under the name Jakafi(®) for the
treatment of patients with intermediate or high-risk myelofibrosis.
As part of the Novartis clinical development program, Jakavi is also being
investigated in clinical trials for the treatment of polycythemia vera[10].
Jakavi is a registered trademark of Novartis AG in countries outside the United
States.
Jakavi(®) Important Safety Information
Jakavi(®) can cause serious side effects, including a decrease in blood cell
count and infections. Complete blood count monitoring is recommended. Dose
reduction or interruption may be required in patients with severe hepatic or
renal impairment or in patients developing hematologic adverse reactions such as
thrombocytopenia, anemia and neutropenia. Dose reductions are also recommended
when Jakavi is co-administered with strong CYP3A4 inhibitors or fluconazole. Use
of Jakavi during pregnancy is not recommended and women should avoid becoming
pregnant during Jakavi therapy. Women taking Jakavi should not breast feed.
The most common adverse drug reactions (incidence >10%) are urinary tract
infections, anemia, thrombocytopenia, neutropenia, hypercholesterolaemia,
dizziness, headache, alanine aminotransaminase increased, asparte
aminotransferase increased, bruising, bleeding and increased blood pressure.
Other common adverse drug reactions (incidence 1 to 10%) are herpes zoster,
weight gain, flatulence and tuberculosis.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "committed," "potentially," "being
investigated," or similar expressions, or by express or implied discussions
regarding potential additional marketing approvals for Jakavi, or regarding the
potential approval of new indications or labeling for Jakavi, and the timing of
any such approvals, or regarding potential future revenues from Jakavi. 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 with Jakavi to be materially different from any future results,
performance or achievements expressed or implied by such statements. There can
be no guarantee that Jakavi will be approved for sale in any additional markets,
or for any additional indications or labeling, or at any particular time.
Neither can there be any guarantee that Jakavi will achieve any particular
levels of revenue in the future. In particular, management's expectations
regarding Jakavi could be affected by, among other things, unexpected regulatory
actions or delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected additional
analysis of existing clinical data; government, industry and general public
pricing pressures; unexpected manufacturing issues; competition in general; the
company's ability to obtain or maintain patent or other proprietary intellectual
property protection; 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 or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2011, the Group
achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD
9.2 billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Novartis Group companies employ approximately 126,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
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References
[1] Mesa RA, Schwagera S, Radia D, et al. The Myelofibrosis Symptom Assessment
Form (MFSAF): an evidence-based brief inventory to measure quality of life and
symptomatic response to treatment in myelofibrosis. Leuk Res. 2009;33:1199-1203.
[2] Girodon F, Bonicelli G, Schaeffer C, et al. Significant increase in the
apparent incidence of essential thrombocythemia related to new WHO diagnostic
criteria: a population-based study. Haematologica. 2009; 94(6):865-869.
[3] McNally RJQ, Rowland D, Roman E, Cartwright RA. Age and sex distributions of
hematological malignancies in the U.K. Hematol Oncol. 1997;15:173-189.
[4] Harrison C, Kiladjian JJ, Al-Ali HK, et al. JAK Inhibition with Ruxolitinib
versus Best Available Therapy for Myelofibrosis. New Eng J Med. 2012: March
1;366:787-98.
[5] Verstovsek S, Mesa RA, Gotlib J, et al. A Double-Blind, Placebo-Controlled
Trial of Ruxolitinib for Myelofibrosis. New Eng J Med. 2012: March
1;366:799-807.
[6] Hasselbach, H. Perspectives on chronic inflammation in essential
thrombocythemia, polycythemia vera, and myelofibrosis. Blood. 2012. Epub ahead
of print February 7.
[7] Verstovsek S, Kantarjian H, Mesa RA, et al. Safety and Efficacy of JAK1 &
JAK2 Inhibitor, INCB018424, in Myelofibrosis. New Eng J Med. 2010 September
16;363:1117-1127.
[8] Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring system for
primary myelofibrosis based on a study of the International Working Group for
Myelofibrosis Research and Treatment. Blood. 2009;113:2895-2901.
[9] Patriarca F, Bacigalupo A, Sperotto A, et al. Allogeneic hematopoietic stem
cell transplantation in myelofibrosis: the 20-year experience of the Gruppo
Italiano Trapianto di Midollo Osseo (GITMO). Haematologica.
2008;93(10):1514-1522.
[10] National Institutes of Health. Study of Efficacy and Safety in Polycythemia
Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor
JAKAVI (INCB018424) Tablets Versus Best Available Care: The RESPONSE Trial.
Available at
http://www.clinicaltrials.gov/ct2/show/NCT01243944?term=ruxolitinib&rank=14.
Accessed January 31, 2012.
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Datum: 28.08.2012 - 07:15 Uhr
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