'Nexium' Receives Fast First Approval in Sweden
AstraZeneca PLC
13 March 2000
ASTRAZENECA'S 'NEXIUM' RECEIVES FAST FIRST APPROVAL IN SWEDEN WITH WIDE RANGE
OF INDICATIONS
AstraZeneca today announced the initial approval of 'Nexium' (esomeprazole)
with fast clearance given by the Swedish Medical Product Agency (MPA) for a
broad range of indications, including two new treatment approaches.
Based on extensive clinical studies involving more than 15,000 patient
treatments, 'Nexium' has received approval for both initial and long-term
management of gastro-esophageal reflux disease (GERD), healing of H.
pylori-associated duodenal ulcers and prevention of relapse of peptic ulcer
disease.
This is based on studies showing:
- fast healing of reflux esophagitis
- fast symptom relief
- a new approach to long term management of symptomatic GERD
- a new approach to H. pylori treatment
'Nexium' demonstrates advanced clinical efficacy and predictability beyond
that achieved by omeprazole, the current gold standard of treatment, and is a
significant advance in the management of acid-related disease.
The Swedish MPA will act as rapporteur for the European Mutual Recognition
Procedure to obtain approval in 14 other member states in the EU with launches
in a number of these countries anticipated before the end of the year. Launch
plans are developed for 'Nexium' and sales in Sweden will start in the second
half of this year (2000). 'Nexium' is also awaiting approval in the USA
(launch expected early 2001), and in other markets.
Patient benefits achieved with 'Nexium' include greater predictability of
response, improved symptom control and healing. Studies have also shown that
acid control with 'Nexium' is greater, faster and more sustained compared to
other proton pump inhibitors (PPIs). 'Nexium' is metabolised in such a way
that more of the drug is delivered to the site of action, leading to superior
acid control.
Clinical studies in patients with heartburn and reflux esophagitis show that
the healing rates achieved by 'Nexium' in four weeks match those attained by
omeprazole in eight weeks, demonstrating potential for health economic
benefits.
The broad indication base includes two new treatment approaches for 'Nexium' -
the healing of H. pylori-associated duodenal ulcer, with one week treatment,
without the need for subsequent monotherapy and the symptom-driven 'on-demand'
treatment for management of recurrent heartburn and other symptoms of GERD.
'On-demand' treatment allows doctors to prescribe 'Nexium' to patients, who
then take the medication once daily, when needed, to control their recurrent
symptoms. This is a new, highly convenient, and cost effective approach to
the long-term control of the symptoms of GERD. Clinical studies have
demonstrated that after six months' treatment, 90 per cent of patients can
control symptoms effectively by taking 'Nexium', on-demand. 'Nexium' is
the first and only PPI to gain approval for this new treatment of symptomatic
GERD.
AstraZeneca, invented the PPI drug class with 'Losec' (omeprazole), currently
the world's top selling branded pharmaceutical product. With 'Nexium',
AstraZeneca has achieved an evolution in the management of acid-related
diseases and has underscored the company's commitment to optimising treatment
in the field of gastroenterology.
'Nexium' will enter a global market worth USD 12.6bn in 1999 with an estimated
10 per cent of the population thought to suffer from peptic ulcer disease and
an even higher proportion with acid-related reflux disease. Further clinical
data on 'Nexium' will be published at the Digestive Diseases Week conference
in San Diego, USA, in May.
Further enquires to -
Michael Olsson: Tel. +44 (0)20 7304 5087
Elizabeth Sutton: Tel. +44 (0)20 7304 5101
Ed Seage: Tel. +1 302 886 4065
Jorgen Winroth: Tel. +1 609 896 4148
+44(0)7715 011140
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