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news.European Medicine Agency (EMA) has approved Helsinn Group's Palonosetron 0.5mg soft gelatine capsule oral formulation for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy (MEC) in adults.
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Helsinn Group said that Palonosetron (palonosetron hydrochloride) is a second generation 5-HT3 Receptor Antagonist, developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer, with a long half-life of 40hours.
The European Marketing Authorisation for the oral formulation of palonosetron, licensed by the Swiss pharmaceutical group Helsinn, follows the approval obtained in August 2008 in the USA.
Helsinn Group claimed that Palonosetron demonstrates, in clinical trials and clinical practice, long-lasting action in the prevention of CINV. The product has shown to be effective in preventing both acute and delayed CINV in patients receiving Moderately Emetogenic Chemotherapy (MEC).
Riccardo Braglia, CEO of Helsinn Group, said: “As proven by our product pipeline, Helsinn is committed to Cancer Supportive Care and we are delighted that cancer patients suffering from nausea and vomiting can now benefit from oral Aloxi beside the injectable form.
“We expect this will allow palonosetron to strengthen its position in the chemotherapy-induced nausea and vomiting (CINV) prevention.”