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FDA Approves AstraZenecas Nexium(TM) With Comprehensive Set of Indications
Article
AstraZeneca
News release 02/21/2001 05:55:33 AM GMT
(PRESSI.COM 02/21/2001)
AstraZeneca confirms it will launch Nexium(TM) during March in the US, following its approval by the US Food and Drug Administration (FDA) and the announcement of the catalogue price to wholesalers.
Tom McKillop, Chief Executive of AstraZeneca said, "We are delighted to receive FDA approval for all indications sought for Nexium(TM). The US label compares favourably with both the US Prilosec label and with those received so far in Europe for Nexium(TM) which has had launches among the best in the pharmaceutical industry's history. Nexium(TM) will be available on prescription in the US in March.
"We are very well prepared to launch Nexium(TM) in the US and with this label we are confident of retaining our global leadership of the gastro-intestinal market".
The FDA has approved Nexium(TM) with a comprehensive set of indications as follows:
- Heartburn and other symptoms associated with gastroesophageal reflux disease (GERD).
- The healing and symptom resolution of erosive esophagitis, a potentially serious condition associated with GERD.
- The maintenance of both healing and symptom resolution of esophagitis.
- The eradication of Helicobacter pylori infection in patients with duodenal ulcer disease in 10 days, in combination with certain antibiotics.
The label confirms that Nexium(TM) 40mg demonstrates higher healing rates in erosive esophagitis than Prilosec 20mg (the approved dose for this indication). In three studies, Nexium(TM) 40mg consistently demonstrated higher healing rates than Prilosec 20mg and two of these studies were statistically significant. Healing rates achieved for Nexium(TM) 20mg were between those achieved with Nexium(TM) 40mg and Prilosec 20mg.
Sustained resolution of heartburn was achieved in 5 days for Nexium(TM) 40mg; 7 - 8 days for Nexium(TM) 20mg against 7 - 9 days for Prilosec 20mg. After four weeks of 40mg Nexium(TM) treatment, a higher percentage of patients achieved sustained resolution of heartburn than with Prilosec 20mg.
In clinical trials, the safety profile of Nexium(TM) was similar to that of Prilosec. The most frequently occurring side effects were headache, diarrhoea and abdominal pain.
The catalogue price to wholesalers has been set at $3.33 for either a Nexium(TM) 20mg or Nexium(TM) 40mg capsule. The catalogue price to wholesalers of Prilosec 20mg is 3.45.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15.8 billion and leading positions in cardiovascular, gastrointestinal, oncology, anaesthesia including pain management, central nervous system (CNS) and respiratory products.
The US Nexium(TM) label is available on the US AstraZeneca website, www.astrazeneca-us.com.
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References:
February 2001
www.pressi.com/int/release/27003.html
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