Study suggests experimental Karo Bio drug could lower bad cholesterol
STOCKHOLM, Sweden According to a new study, the Karo Bio AB drug KB2115 can lower the levels of low-density lipoprotein or bad cholesterol by as much as 40 percent and reduce heart disease risks, the Washington Post reported.
The study was a phase II clinical trial, which studied 24 moderately overweight people with high LDL levels. The tests confirmed earlier studies with animals. The researchers involved though all have a stake in Karo.
The drug is designed to copy the action of a thyroid hormone and accelerates the hormone’s natural ability to rid the body of LDL. Since it is unrelated in structure or action to widely-used cholesterol lowering statin drugs (such as Lipitor, Pravachol and Zocor), KB2115 may offer an alternative for patients who can’t tolerate statins, according to the study authors. It may also be possible to use KB2115 to further decrease cholesterol levels in patients taking statins.
Mylan, Forest get FDA approval of Bystolic for hypertension
WASHINGTON The Food and Drug Administration has approved Mylan and Forest Labs’ new drug, nebivolol, for the treatment of high blood pressure. Forest will market the drug under the prescription name Bystolic.
Nearly 1-in-3 adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack and kidney failure. “High blood pressure is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” said Douglas Throckmorton, the FDA’s deputy director of the Center for Drug Evaluation and Research. “Bystolic offers a new treatment option for people who need to control their high blood pressure.”
More than 2,000 people received Bystolic during clinical trials. The drug’s efficacy was similar to that of other approved beta blockers, the FDA said. The most common reported side effects were headache, fatigue, dizziness and diarrhea.
On Dec. 2 of this year, Forest and Mylan had said that final approval was contingent upon resolution of manufacturing deficiencies at a plant in Belgium.
Genzyme gets expanded approval for Thyrogen from FDA
CAMBRIDGE, Mass. The Food and Drug Administration has granted expanded approval for Genzyme’s thyroid cancer drug Thyrogen, according to published reports.
The new indication allows for Thyrogen (thyrotrophin) to be used in combination with radioiodine, a radioactive iodine used to treat thyroid cancer, to destroy the remaining thyroid tissue in patients who have had their cancerous thyroids removed.
Thyrogen was initially approved in the U.S. in 1998 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The drug helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal.
“This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence,” said Mike Heslop, senior vice president and general manager of Genzyme’s endocrine business.