Novartis drug Signifor® recommended by FDA advisory committee for approval to treat patients with Cushing's disease
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Novartis drug Signifor® recommended by FDA advisory committee for approval to
treat patients with Cushing's disease
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* Committee votes unanimously in favor of Signifor (pasireotide) as the first
medication to treat US patients with Cushing's disease
* Pasireotide represents the first targeted approach for this potentially
debilitating endocrine disorder caused by a pituitary tumor that triggers
excess cortisol[1],[2]
* Majority of patients in the Phase III clinical trial experienced a rapid and
sustained decrease in mean cortisol levels with subset of patients achieving
normalization[3]
Basel, November 7, 2012 - The US Food and Drug Administration's (FDA)
Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted
unanimously in support of the use of Signifor(®) (pasireotide) for the treatment
of patients with Cushing's disease who require medical therapeutic intervention.
"We are encouraged by today's favorable advisory committee recommendation for
pasireotide in Cushing's disease and will work closely with the FDA as it
completes its review of our application," said Hervé Hoppenot, President,
Novartis Oncology. "There is a significant unmet medical need for Cushing's
disease patients and Novartis is committed to providing the endocrinology
community with a novel therapeutic approach for this rare and debilitating
endocrine disorder."
The recommendation was based on data from clinical trials of pasireotide,
including PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S
disease), the largest randomized Phase III study to evaluate a medical therapy
in patients with Cushing's disease. Although not obliged to follow the
recommendation, the FDA can seek the advice of its advisory committees as it
reviews and decides whether to approve treatments[1],[4].
Results from the PASPORT-CUSHINGS study found that mean urinary-free cortisol
(UFC), the key measure of biochemical control of the disease, was rapidly
decreased and sustained in a majority of patients, with a subset of patients
reaching normalized levels. The study also showed that, on average, as UFC
levels were reduced, clinical manifestations of Cushing's disease improved. The
most frequently reported adverse events (AEs) (>10%) by investigators for
pasireotide were diarrhea, nausea, hyperglycemia, cholelithiasis, abdominal
pain, diabetes mellitus, injection site reactions, fatigue and increased
glycosylated hemoglobin (HbA1c), with most events being Grade 1-2. The safety
profile of pasireotide was similar to that of other somatostatin analogs (SSA)
with the exception of the greater degree of hyperglycemia[3].
Cushing's syndrome is an endocrine disorder caused by excessive cortisol, a
vital hormone that regulates metabolism, maintains cardiovascular function and
helps the body respond to stress. Cushing's disease is a form of Cushing's
syndrome, in which excess cortisol production is triggered by an
adrenocorticotropic hormone (ACTH)-secreting pituitary adenoma. It is a rare but
serious disease that affects approximately one to two patients per million per
year. Cushing's disease most commonly affects adults as young as 20 to 50 years
and affects women three times more often than men. It may present with weight
gain, central obesity, a round, red full face, severe fatigue and weakness,
striae (purple stretch marks), high blood pressure, depression and anxiety. The
first line and most common treatment approach for Cushing's disease is surgical
removal of the tumor[1],[2],[5],[6],[7].
About pasireotide
Pasireotide is a multireceptor targeting somatostatin analog (SSA) that binds
with high affinity to four of the five somatostatin receptor subtypes (sst
1, 2, 3 and 5)[2]. In April 2012, the European Commission approved pasireotide
under the brand name Signiforfor the treatment of adult patients with Cushing's
disease for whom surgery is not an option or for whom surgery has failed. Other
worldwide regulatory filings for pasireotide for this use are also underway.
For the treatment of Cushing's disease, pasireotide has been studied as a twice-
daily subcutaneous (sc) injection and is currently being evaluated as a long-
acting release (LAR), once-monthly intramuscular (IM) injection as part of a
global Phase III program in Cushing's disease and acromegaly[8],[9].
There is no guarantee that pasireotide will become commercially available
anywhere else in the world. As an investigational compound, the safety and
efficacy profile of pasireotide has not yet been established in all countries
for the treatment of Cushing's disease or any other indications. Access to
pasireotide outside of the approved indications has been carefully controlled
and monitored in clinical trials designed to better understand the potential
benefits and risks of the compound.
Information about Novartis clinical trials for pasireotide can be obtained by
healthcare professionals at www.pasporttrials.com.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "recommended," "potentially," "encouraged," "will,"
"committed," "recommendation," "underway," "potential," or similar expressions,
or by express or implied discussions regarding potential marketing approvals for
Signifor or regarding potential future revenues from Signifor. 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 Signifor to be materially different from any future results,
performance or achievements expressed or implied by such statements. There can
be no guarantee that Signifor will be approved for sale in any market, or at any
particular time. Nor can there be any guarantee that Signifor will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding Signifor 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; competition in general; unexpected
manufacturing issues; 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's
continuing operations 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 127,000 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] National Endocrine and Metabolic Diseases Information Service. US National
Institutes of Health. Cushing's Syndrome. Available at:
http://endocrine.niddk.nih.gov/pubs/cushings/Cushings_Syndrome_FS.pdf.
Accessed October 2012.
[2] Pedroncelli, A. Medical Treatment of Cushing's Disease: Somatostatin
Analogues and Pasireotide. Neuroendocrinology. 2010;92(suppl1):120-124.
[3] Colao, A. A 12-Month Phase III Study of Pasireotide in Cushing's Disease.
New Engl J Med. 2012; 366(10):914-924.
[4] US Food and Drug Administration. The Federal Advisory Committee Act.
Available at
http://www.fda.gov/downloads/AdvisoryCommittees/AboutAdvisoryCommittees/La
wsRegulationsGuidance/UCM154704.doc. Accessed October 2012.
[5] Lindholm, J., et al. Incidence and Late Prognosis of Cushing's Syndrome: A
Population-Based Study. J Clin Endocrinol Metab. 2001;86(1):117-23.
[6] Newell-Price, J., et al. The Diagnosis and Differential Diagnosis of
Cushing's Syndrome and Pseudo-Cushing's States. Endocrine
Reviews.1998;19(5):647-672.
[7] Bertanga, X., et al. Cushing's Disease. Best Practice & Research Clinical
Endocrinology & Metabolism. 2009;23:607-623.
[8] US National Institutes of Health. Safety and Efficacy of Pasireotide Long
Acting Release (LAR) vs. Octreotide LAR in Patients With Active
Acromegaly. Available at:
http://clinicaltrials.gov/ct2/show/NCT00600886?term=safety+and+efficacy+of
+pasireotide&rank=3. Accessed October 2012.
[9] US National Institutes of Health. Efficacy and Safety of Pasireotide
Administered Monthly in Patients With Cushing's Disease. Available at:
http://clinicaltrials.gov/ct2/show/NCT01374906. Accessed October 2012.
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Datum: 07.11.2012 - 22:26 Uhr
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