Widely anticipated, but not yet available, the new study-results for mipomersen (a HUGE molecule -- click image to enlarge, at right), an Isis candidate -- may once again shake up the cholesterol management drugs' batting order. That could present additional problems for Merck's Vytorin/Zetia. This per Reuters, this morning:
. . . .The drug, mipomersen, is designed to lower "bad" LDL cholesterol in patients with severely high cholesterol.
Isis is expected to report any day now results from two trials: one in patients with high cholesterol who are at high risk of heart disease and another in patients with a condition known as severe hypercholesterolemia.
Trial results released in February showed six months of treatment with the Isis drug lowered LDL cholesterol by 28 percent in patients with heterozygous familial hypercholesterolemia (HeFH) -- caused by a defective gene inherited from one parent.
But some patients developed elevated liver enzymes, a possible sign of liver damage, raising concerns regulators might require more studies. . . .
We'll see.
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