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Palonosetron (Aloxi) approved for prevention of chemotherapy-induced nausea and vomiting

LUGANO, SWITZERLAND, July 28, 2003 -- Helsinn Healthcare SA announced that the FDA had granted marketing approval for its new drug palonosetron, to be known as Aloxi in the U.S.

Under the new approval, palonosetron is indicated for:

  • Prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy; and
  • Prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

"The new indications for palonosetron advance the standards of therapy for delayed emesis due to moderately emetogenic chemotherapy." said Steven M. Grunberg, MD, lead consultant on the palonosetron pivotal program and professor of Medicine and Pharmacology, Fletcher Allen Healthcare, University of Vermont. "Palonosetron is the first 5-HT3 receptor antagonist to be granted approval for prevention of delayed emesis with a single dose in this patient population."

The drug will be commercialized in the U.S. under its new trademark Aloxi, by Helsinn's licensee MGI Pharma, an oncology focused biopharmaceutical company.

Aloxi (palonosetron hydrochloride) injection is a selective 5-HT3 receptor antagonist with strong binding affinity and an extended plasma half-life of approximately 40 hours, which demonstrated efficacy in preventing chemotherapy-induced nausea and vomiting (CINV) in phase 3 clinical trials when compared to currently used 5-HT3 receptor antagonists. These trials were recently presented during the American Society of Clinical Oncology (ASCO) and the Multinational Association of Supportive Care in Cancer (MASCC) conferences held respectively in Chicago and in Berlin.

Helsinn acquired the world-wide rights to palonosetron from Syntex in 1998 while the drug was in phase 2 development and established a complete development program in the US and in Europe involving over 1800 patients. The palonosetron NDA was submitted in September 2002. Helsinn granted the US and Canadian distribution and licensing rights to MGI Pharma in April 2001.

If not prevented CINV is estimated to afflict 85 per cent of cancer patients undergoing chemotherapy and can result in a delay or even discontinuation of chemotherapy treatment. The advent of 5-HT3 receptor antagonists, some ten years ago, has revolutionised the management of nausea and vomiting experienced by cancer patients undergoing chemotherapy.

Palonosetron is a selective 5-HT3 receptor antagonist with a strong receptor-binding affinity and an extended plasma half-life of approximately 40 hours. Altogether, approximately 2,800 patients or subjects have participated in its clinical trials. Palonosetron extended duration of action has been successfully demonstrated in these clinical trials.

In clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 1374 adult patients received palonosetron. Adverse reactions were similar in frequency and severity with Aloxi and the comparator agents. The most common adverse reactions related to the study drug at a dose of 0.25 mg were headache (9%) and constipation (5%). The effect of Aloxi on ECG parameters was comparable to ondansetron and dolasetron in clinical trials; it should be administered with caution in patients who have or may develop prolongation of cardiac conduction intervals. See the Aloxi package insert for important additional details.

Source: Helsinn

Posted: July 2003