By Lisa Beilfuss
Shares in Regeneron Pharmaceuticals Inc. are halted Tuesday,
ahead of a U.S. Food & Drug Administration advisory committee's
review of its experimental cholesterol-lowering drug Praluent.
Regeneron partnered with France's Sanofi SA in developing the
medicine. The companies in January won priority review for
Praluent, or alirocumab. The injectable drug is a new low-density
lipoprotein-lowering agent that would be among the first major
additions to the coronary heart-disease medicine chest since statin
pills were first prescribed in the late 1980s.
Amgen Inc. has developed a similar drug--evolocumab--which goes
before the FDA's advisory panel on Wednesday.
The new drugs block PCSK9, a protein that interferes with the
liver's ability to clear "bad" LDL cholesterol.
Alirocumab ultimately acts by regulating the same functional
target as statins, the FDA Endocrinologic & Metabolic Drugs
Advisory Committee said, but the intended population for alirocumab
treatment are patients who require reductions in LDL cholesterol
levels beyond that attainable by a maximally tolerated dose of
statin.
Statins include Pfizer Inc.'s Lipitor and AstraZeneca PLC's
Crestor.
Regeneron and Sanofi have said they expect FDA clearance for
Praluent by July 24.
Advisory-panel recommendations aren't binding but are considered
by the FDA and often foreshadow the final decision.
Regeneron shares have gained 28% this year through Monday's
close. Shares in Sanofi, meanwhile, are up 8.5% this year.
Write to Lisa Beilfuss at lisa.beilfuss@wsj.com
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