Monday, September 04, 2006
Novartis' Exjade Receives European Commission Approval As New Treatment For Iron Overload
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Wednesday, August 30, 2006; Posted: 05:13 AM
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(RTTNews) - Early Wednesday, Basel, Switzerland-based healthcare company Novartis AG (NVS | charts | news | PowerRating) announced the European Commission or EC's approval for Exjade as a new treatment for patients with transfusional iron overload. The company said that the EC approved the drug in all 25 member states of the European Union or EU.
According to the company, iron overload is a potentially life-threatening consequence of frequent blood transfusions. After a few transfusions, iron starts to build up in the body as the body cannot remove it by its own. In iron chelation, an agent binds to iron in the body and helps remove it through the urine or feces.
Novartis said that Exjade is the first oral iron chelator approved in the EU for the treatment of chronic iron overload due to frequent blood transfusions in patients age six and older with beta thalassemia major, myelodysplastic syndromes, sickle cell disease and other anemias. Exjade is administered once-daily as a drink. This drug provides continuous chelation with the single daily dose. The drug also removes highly toxic labile plasma iron from liver and heart, the company noted.
Novartis also said that deferoxamine, the standard iron chelator used globally, requires nightly infusions by needle and pump, which often takes eight to 12 hours per night for five to seven nights in a week.
Novartis further stated that during the clinical trials for Exjade, data from more than 1,000 patients with a broad range of underlying diseases showed that the drug is effective in reducing excessive body iron, especially in patients with moderate to severe iron overload. While the main Phase III study demonstrated that Exjade as effective as deferoxamine, a sub-study indicated the drug's efficacy in reducing the content of iron in the heart.
The company also stated that the drug was generally well tolerated in the clinical trials. The most frequently reported adverse events were nausea, vomiting, diarrhea, abdominal pain, skin rash and increases in serum creatinine.
As per the company, before granting the approval, the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMEA issued a positive opinion recommending marketing authorization. The drug has already been approved in 29 countries and has been designated an orphan drug in the EU, U.S., Switzerland and Australia. The company also stated that additional regulatory submissions for Exjade have been made around the world.
On the NYSE, NVS closed Tuesday's regular trading session at $57.50, up $0.52, on a volume of 1.08 million shares.
Copyright(c) 2006 RealTimeTraders.com, Inc. All Rights Reserved
Wednesday, August 30, 2006; Posted: 05:13 AM
Find out where NVS is going
Use our most popular trading tool to find
out how NVS will move in the next
5 days.
Stocks rated 9 and 10 have outperformed the average stock by approximately 14 to 1 since 1995 and ideally are the stocks to focus on each day. Stocks rated 1 and 2 on average have lost money and you want to know these stocks in order to avoid them.
Click here for more details
(RTTNews) - Early Wednesday, Basel, Switzerland-based healthcare company Novartis AG (NVS | charts | news | PowerRating) announced the European Commission or EC's approval for Exjade as a new treatment for patients with transfusional iron overload. The company said that the EC approved the drug in all 25 member states of the European Union or EU.
According to the company, iron overload is a potentially life-threatening consequence of frequent blood transfusions. After a few transfusions, iron starts to build up in the body as the body cannot remove it by its own. In iron chelation, an agent binds to iron in the body and helps remove it through the urine or feces.
Novartis said that Exjade is the first oral iron chelator approved in the EU for the treatment of chronic iron overload due to frequent blood transfusions in patients age six and older with beta thalassemia major, myelodysplastic syndromes, sickle cell disease and other anemias. Exjade is administered once-daily as a drink. This drug provides continuous chelation with the single daily dose. The drug also removes highly toxic labile plasma iron from liver and heart, the company noted.
Novartis also said that deferoxamine, the standard iron chelator used globally, requires nightly infusions by needle and pump, which often takes eight to 12 hours per night for five to seven nights in a week.
Novartis further stated that during the clinical trials for Exjade, data from more than 1,000 patients with a broad range of underlying diseases showed that the drug is effective in reducing excessive body iron, especially in patients with moderate to severe iron overload. While the main Phase III study demonstrated that Exjade as effective as deferoxamine, a sub-study indicated the drug's efficacy in reducing the content of iron in the heart.
The company also stated that the drug was generally well tolerated in the clinical trials. The most frequently reported adverse events were nausea, vomiting, diarrhea, abdominal pain, skin rash and increases in serum creatinine.
As per the company, before granting the approval, the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMEA issued a positive opinion recommending marketing authorization. The drug has already been approved in 29 countries and has been designated an orphan drug in the EU, U.S., Switzerland and Australia. The company also stated that additional regulatory submissions for Exjade have been made around the world.
On the NYSE, NVS closed Tuesday's regular trading session at $57.50, up $0.52, on a volume of 1.08 million shares.
Copyright(c) 2006 RealTimeTraders.com, Inc. All Rights Reserved
