FDA to evaluate CV Theraputics’ Ranexa claims
PALO ALTO, Calif. The Food and Drug Administration has notified CV Therapeutics that it will evaluate the approval of potential anti-arrhythmic claims for Ranexa, according to Reuters. Ranexa is approved for the treatment of chronic angina in patients who already are using amlodipine, beta-blockers or nitrates.
This follows the FDA’s acceptance of two supplemental and one new drug application for Ranexa. The two supplemental applications state that Ranexa’s labeling should include a first-line angina indication and a significant reduction in cautionary language. The new drug application calls for a labeling change to add reduction of hemoglobin A1c in coronary artery disease patients with diabetes.
“We anticipate receiving approval for first-line angina use, which would significantly expand the patient population eligible to receive Ranexa, and we are very pleased that the FDA also is now evaluating separate potential anti-arrhythmic and HbA1c reduction claims for Ranexa on the same timeline,” said Louis Lange, CV Therapeutics’ chairman and chief executive officer.
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.