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Helsinn Healthcare SA

Helsinn Healthcare SA Announces Aloxi sNDA for PONV accepted for review by U.S. FDA

Lugano (ots)

PDUFA date of 4th March 4, 2008 established
Helsinn's Top Management today announced that the
supplemental New Drug Application (sNDA) for Aloxi® (palonosetron
hydrochloride) Injection for the prevention of post-operative nausea
and vomiting was accepted for filing by the United States Food and
Drug Administration (FDA). Aloxi is approved by the FDA for the
prevention of acute nausea and vomiting associated with initial and
repeat courses of moderately and highly emetogenic cancer
chemotherapy and for the prevention of delayed nausea and vomiting
associated with initial and repeat courses of moderately emetogenic
cancer chemotherapy.
The sNDA for Aloxi Injection was submitted to the FDA on May 7,
2007. The acceptance for review of the NDA represents the FDA's
determination that the application is sufficiently complete to permit
a substantive review of the data. The filing of the application by
the FDA does not represent any opinion regarding the safety, efficacy
or approvability of Aloxi Injection. Under PDUFA (Prescription Drug
User Fee Act) III, the FDA's goal is to review and act on the NDA by
March 4, 2008.
The sNDA included data from two randomized, multi-center, phase 3
trials conducted to evaluate the safety and efficacy of three doses
of Aloxi compared to placebo for the prevention of PONV.  In these
two trials, a total of 1,219 patients undergoing elective outpatient
abdominal or gynecological laparoscopic surgery (Study PALO-04-06) or
elective inpatient gynecological or breast surgery (Study PALO-04-07)
were randomized to receive one of three single intravenous doses of
Aloxi or placebo prior to administration of anesthesia.  Data were
collected to examine the effectiveness and safety of Aloxi during the
time course of patient risk for nausea and vomiting, regardless of
inpatient or outpatient site of postoperative care on the day of
surgery and for two more days (0-72 hrs).  Both clinical trials
successfully met the primary efficacy endpoint of complete response,
defined as no emesis or use of rescue medication, for the 0-24 hour
time period and the key secondary efficacy endpoint of complete
response for the entire 0-72 hour time period following surgery, for
the proposed dose of 0.075 mg. The incidence, pattern, and intensity
of adverse events were similar among all treatment groups including
placebo, and the most frequently observed side effects were headache
and constipation.
About Post-Operative Nausea and Vomiting (PONV)
Post-operative nausea and vomiting are common consequences of
anesthetic and surgical procedures, frequently occurring immediately
following the procedure and up to 72 hours post procedure.  In the
United States, nearly 30 million doses of 5-HT3 receptor antagonists
are used annually for the management of PONV.  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.  If not prevented, PONV can result
in hospital re-admissions and increased healthcare costs in
approximately 58% of patients who undergo surgery.
About Aloxi® Injection
Aloxi is currently being evaluated in a clinical program designed
to evaluate its safety and efficacy in post-operative nausea and
vomiting, but it is not approved for this indication. Aloxi is
approved by the U.S. FDA for the prevention of acute nausea and
vomiting associated with initial and repeat courses of moderately and
highly emetogenic cancer chemotherapy and for the prevention of
delayed nausea and vomiting associated with initial and repeat
courses of moderately emetogenic cancer chemotherapy.  Aloxi is the
first and only 5-HT3 receptor antagonist to be indicated for the
prevention of delayed chemotherapy-induced nausea and vomiting (CINV)
caused by moderately emetogenic cancer chemotherapy.  The most common
adverse reactions related to Aloxi were headache (9%) and
constipation (5%).  Please see the Aloxi package insert, available
www.mgipharma.com and www.aloxi.com, for important additional
details.
About HELSINN HEALTHCARE
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
Rachid BenHamza, Ph.D.,
Commercial Operations
Tel: +41/91/985'21'21
E-mail: rbh@helsinn.com

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