WASHINGTON, Feb 10 (Reuters) -- US health officials on Wednesday approved
Glaxo Wellcome Plc's Lotronex, a drug considered a promising new treatment for
millions of Americans with a bowel disorder.
The Food and Drug Administration (FDA) cleared Lotronex for relieving a
variety of symptoms caused by irritable bowel syndrome (IBS), an agency
spokesperson said.
Lotronex is expected to sell briskly, possibly with sales of $1 billion a
year, because IBS affects so many people and current treatments provide only
limited relief, industry analysts have said.
IBS causes a range of symptoms including severe abdominal pain, diarrhea
and constipation. The severity of the disorder varies, but it can be so serious
that it disrupts normal activities, causes people to miss school or work, and
forces patients to stay close to a restroom.
The FDA approval means Glaxo will be first to hit the untapped market for
IBS treatments, beating other rivals such as the Swiss pharmaceutical firm
Novartis AG, which is developing a treatment for IBS known as Zelmac.
Lotronex is considered likely to be one of the most successful new
products from British drugs group Glaxo, which has announced plans to merge with
SmithKline Beecham to form the world's largest pharmaceutical company.