Safer Diabetes Drugs Foreseen New Medicines Could Replace Rezulin
February 14, 1999
ABCNEWS.com
— Drug makers SmithKline Beecham Plc and
Eli Lilly & Co. are expected to shake up the
U.S. diabetes market this year with safer new
medicines against the most common form of the
disease.
The new drugs could threaten Warner-Lambert Co.'s
controversial drug Rezulin.
Rezulin (troglitazone), launched in early 1997 and
generating 1998 U.S. sales of $748 million, could soon
face stiff competition from SmithKline's planned entrant,
Avandia (rosiglitazone), and Eli Lilly's product, Actos
(pioglitazone).
Both of the newcomers are awaiting approval from the
U.S. Food and Drug Administration and could become
blockbusters with annual sales of more than $1 billion,
analysts said.
15 Million Affected
All three drugs are members of a new (thiazolidinedione)
class of oral drugs against Type II diabetes, which
typically strikes in adulthood and is closely linked to
obesity. They work by improving the ability of the body's
insulin to remove glucose from the bloodstream.
Type II diabetes affects 15 million Americans and can
lead to devastating complications such as blindness, limb
amputations and nerve damage.
“This looks like the most promising class of drugs yet
to be seen against Type II diabetes, which is a huge and
growing market because the population is ageing and
becoming more obese,” Hambrecht & Quist drug analyst
Alex Zisson said.
“You can expect a war between Rezulin, Avandia and
Actos,” Zisson said, noting that none of the drugs have yet
been tested against each other in head-to-head trials.
Deaths Linked to Rezulin
Older standard drugs fight the disease by increasing the
amount of insulin made in the pancreas or by reducing the
amount of sugar made by the liver.
Patients with the other form of diabetes, the Type I
inherited autoimmune disorder that accounts for only 10
percent of diabetes cases, depend on insulin injections
beginning in childhood.
More than 1.4 million Americans have taken Rezulin
since it was introduced in 1997. But its sales have been
crimped by concerns over dozens of U.S. patient deaths
linked to the drug, which can cause severe liver toxicity.
On March 26, an FDA advisory panel will publicly
review Rezulin's safety record in the wake of highly
critical ABC and CBS television reports about the pill.
About 1.8 percent of Rezulin patients show evidence
of liver toxicity and one patient in every 35,000 has a
“severe” liver reaction, said Dr. Harvey Katzeff of Long
Island Jewish Hospital, who is a senior official of the
American Diabetes Association.
Carl Gordon, a drug analyst for OrbiMed Advisors in
New York, said SmithKline and Lilly have already stated
that their drugs do not appear to cause liver damage or
other significant side effects.
Fast-Track Review
“So when Avandia and Actos are available, doctors may
opt for them over Rezulin to avoid its slight risk of liver
toxicity,” Gordon said.
Avandia has received fast-track review by the FDA
and could hit U.S. drugstores by June, said Neil Sweig, an
analyst for Southeast Research Partners. He said Actos
could be launched a few months later if it also wins
six-month priority FDA review.
Sweig noted that Rezulin is now administered alone or
in combination with insulin. But he predicted Rezulin,
Avandia and Actos within a few years will each be given
alone or in an array of possible combinations.
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