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Helsinn Healthcare SA

FDA approves ALOXI® (Palonosetron HCl) injection for prevention of postoperative nausea and vomiting

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Helsinn Healthcare SA, a Swiss pharmaceutical
group, together with its partner EISAI Corporation of North America
and EISAI's  U.S. subsidiary, MGI Pharma, Inc., today announced that
the U.S. Food and Drug Administration (FDA) has approved Aloxi®
(palonosetron hydrochloride) injection for the prevention of
postoperative nausea and vomiting (PONV) for up to 24 hours following
surgery. Efficacy beyond 24 hours has not been demonstrated.
Aloxi, available in the United States since 2003, is the first and
only 5-hydroxytryptamine-3 (5-HT3) receptor antagonist approved by
the FDA for the prevention of acute and delayed nausea and vomiting
associated with initial and repeat courses of moderately emetogenic
chemotherapy, and for the prevention of acute nausea and vomiting
associated with initial and repeat courses of highly emetogenic
chemotherapy.
The new indication is based on one double-blind Phase III study
that evaluated the efficacy of three doses of Aloxi compared to
placebo for the prevention of PONV. In the trial, 574 patients
undergoing elective gynecologic or abdominal laparoscopic surgery
(predominately in the out-patient setting) were randomized to receive
one of three single intravenous doses of Aloxi (0.025 mg, 0.050 mg or
0.075 mg) or placebo prior to administration of anesthesia. The
effectiveness of Aloxi in PONV was assessed on the day of surgery
(0-24 hours) and for two subsequent days (24-72 hours).
The trial successfully met its co-primary endpoint of Complete
Response (CR) - defined as no emesis (vomiting) or use of rescue
medication - for the 0-24-hour time period (42.8% of patients treated
with the approved dose of Aloxi 0.075 mg experienced a CR, compared
to 25.9% of patients given placebo [p=0.0035]). For the co-primary
endpoint of CR for the 24-72-hour postoperative period, 48.6% of
patients treated with Aloxi 0.075 mg experienced a CR, compared to
40.7% of patients given placebo (p=0.1877, not significant).
Further, Aloxi 0.075 mg reduced the severity of nausea compared to
placebo, and this was supported by Phase II PONV trial results
demonstrating that Aloxi significantly reduced the severity of nausea
compared to placebo (p=0.009).
The incidence of adverse reactions was indistinguishable among all
treatment groups, including placebo. The most frequently observed
side effects with Aloxi equal to or greater than 2% were
electrocardiogram (ECG) QT prolongation (5%), bradycardia (4%),
headache (3%), and constipation (2%).
Included in the updated label with the PONV indication are the
results of a study, in 221 healthy volunteers, on the effects of
Aloxi at doses of 0.25 mg, 0.75 mg and 2.25 mg, compared to
moxifloxacin, on several ECG intervals, a potential safety concern of
drugs in the 5-HT3 receptor antagonist class. The study demonstrated
that Aloxi had no significant effect on any ECG interval including
QTc duration (cardiac repolarization) at doses up to 2.25 mg. "This
is an important milestone for Aloxi, given the increasing use of
antiemetic prophylaxis during surgical procedures," said Riccardo
Braglia, CEO, Helsinn Healthcare SA, holder of the Aloxi New Drug
Application and partner of Eisai Corporation of North America. MGI
Pharma, Inc. licensed the North American distribution and marketing
rights for Aloxi from Helsinn.
"These results highlight the unique safety features of Aloxi and
when combined with the clinical results, indicate a favorable
risk/benefit ratio," said Michael Cullen, M.D., Chief Medical
Officer, MGI Pharma, Inc.
"This new indication is in keeping with our human health care
mission to address the unmet medical needs of patients," said Hajime
Shimizu, Chairman and CEO, Eisai Corporation of North America. "A
single intravenous dose of Aloxi can provide anesthesiologists with
an effective option for the prevention of PONV for up to 24 hours."
A recent study indicated that despite the use of multiple
prophylactic agents, 33% of high-risk patients still require rescue
therapy during the first six hours after surgery, and more than 40%
suffer symptoms of PONV severe enough to warrant rescue therapy in
the  24 hours after surgery.
An estimated 38 million general anesthesia procedures are
performed each year in the United States (2006 figures), and 39% of
these - 15 million procedures - utilize anti-emetic therapy for PONV.
Of these 15 million procedures, 89%, or 13.4 million, use 5-HT3
receptor antagonists, such as Aloxi.
About Postoperative Nausea and Vomiting (PONV)
Postoperative nausea and vomiting are common consequences of
anesthetic and surgical procedures, and frequently occur following
the procedures. Patients undergoing abdominal, gynecological,
ear/nose/throat, or optical procedures are at highest risk for PONV.
Additional factors that can increase the risk for PONV include female
gender, non-smoking status, prior history of PONV or motion sickness,
length of surgery and the use of volatile anesthetics and opioids.
About Aloxi® Injection
In addition to the new PONV indication, Aloxi (palonosetron HCl)
injection 0.25 mg is the first and only 5-HT3 receptor antagonist to
be indicated for the prevention of acute and delayed nausea and
vomiting associated with initial and repeat courses of moderately
emetogenic chemotherapy, and for the prevention of acute nausea and
vomiting associated with initial and repeat courses of highly
emetogenic chemotherapy.
Aloxi is contraindicated in patients known to have
hypersensitivity to the drug or any of its components. The most
commonly reported adverse reactions in Aloxi chemotherapy-induced
nausea and vomiting trials include headache (9%) and constipation
(5%). Please see the Aloxi package insert, available at
www.aloxi.com, for important additional details.
About Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of
Eisai Co., Ltd., a research-based human health care (hhc) company
that discovers, develops and markets products throughout the world.
Eisai focuses its efforts in three therapeutic areas: neurology,
gastrointestinal disorders and oncology/critical care.
Eisai Corporation of North America supports the activities of its
operating companies in North America. These operating companies
include: Eisai Research Institute of Boston, Inc., a discovery
operation with strong organic chemistry capabilities; Morphotek,
Inc., a biopharmaceutical company specializing in the development of
therapeutic monoclonal antibodies; Eisai Medical Research Inc., a
clinical development group; Eisai Inc., a commercial operation with
manufacturing and marketing/sales functions; MGI Pharma, INC.; and
Eisai Machinery U.S.A., which markets and maintains pharmaceutical
manufacturing machinery. For more information about Eisai, please
visit www.eisai.com.
About MGI PHARMA, INC.
MGI Pharma, Inc., a wholly-owned subsidiary of Eisai Corporation
of North America, is a biopharmaceutical company focused in oncology
and acute care that acquires, researches, develops, and
commercializes proprietary products that address the unmet needs of
patients. For more information about MGI Pharma, Inc., please visit
www.mgipharma.com.
About HELSINN HEALTHCARE SA
HELSINN HEALTHCARE SA is a privately owned pharmaceutical group
with headquarters in Switzerland and is the worldwide licensor of
palonosetron. HELSINN's core business is the licensing of
pharmaceuticals in therapeutic niche areas. The company's business
strategy is to in-license early stage new chemical entities and
complete their development from the performance of
pre-clinical/clinical studies and CMC development to the attainment
of market approvals in strategic markets (U.S. and Europe). HELSINN's
products are eventually out-licensed to its marketing partners for
distribution. The active pharmaceutical ingredients and the finished
dosage forms are manufactured at HELSINN's cGMP facilities and
supplied worldwide to its customers. For more information about
HELSINN, please visit the company's Web site at www.helsinn.com.

Contact:

HELSINN HEALTHCARE SA:
Paolo Ferrari - Head of Marketing -
Oncology & Supportive Care
Tel.: +41-91-985-21-21
E-Mail: info-hhc@helsinn.com

EISAI CORPORATION OF NORTH AMERICA
Judee Shuler
Tel.: +1-201-746-2241

Plus de actualités: Helsinn Healthcare SA
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