FDA approves etravirine for HIV infection
WASHINGTON The Food and Drug Administration has approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.
Etravirine, sold under the name Intelence, helps block an enzyme that HIV needs to multiply. The drug was approved to be used in combination with other anti-HIV medications.
When used with other active anti-HIV medicines, etravirine reduces the amount of HIV in the blood and increases white blood cells that help fight off other infections. In addition, etravirine may reduce the risk of death or infections that can occur with a weakened immune system.
The FDA’s approval of etravirine is based on data from 599 adults who received etravirine in two trials. After 24 weeks of treatment, more of the patients who received etravirine along with background therapy experienced reductions in the level of HIV in their blood than did those who received a placebo and background therapy.
The drug, which is made by Tibotec Therapeutics, was given priority review by the FDA.
Study shows positive results from adding Lipitor early to blood pressure treatment
NEW YORK According to a new study, when Lipitor was added as an early treatment to lower blood pressure, the drug showed a 36 percent reduction in the risk of fatal or non-fatal heart attacks over five years.
The study, entitled Anglo-Scandinavian Cardiac Outcomes Trial, was conducted over a five-year period in Europe with over 19,000 patients, with the first three years being dedicated to comparing Lipitor, a Pfizer product, with a placebo. The additional two years were used for post-study follow up. At the start of the study, patients had high blood pressure and additional cardiovascular risk factors but no coronary heart disease.
“This study highlights the importance of initiating medical treatment for both blood pressure and cholesterol as soon as possible, and raises questions about medical guidelines that do not focus on early intensive treatment of multiple risk factors, notably blood pressure and cholesterol, in patients with moderate cardiac risk,” according to Bryan Williams, chairman of the British Hypertension Society Guideline working party and professor of medicine, University Hospitals NHS Trust, Leicester, United Kingdom.
Patients in ASCOT-LLA had normal to mildly elevated cholesterol levels, were not candidates for lipid-lowering treatment at the time of the study initiation, and received Lipitor 10 mg or a placebo at the outset of the trial.
At the end of the follow-up period, LDL-C or bad cholesterol levels were similar in both groups as a result of Lipitor treatment and the average blood pressure level was significantly reduced from 164/95 mmHg to 137/78 mmHg with the blood pressure lowering therapy.
Taro submits Flo-Pred application to FDA in new PLR format
WASHINGTON Taro Pharmaceuticals applied Thursday to the Food and Drug Administration seeking approval for its new oral solution, Flo-Pred.
Flo-Pred (prednisolone acetate oral suspension) is an anti-inflammatory or immunosuppressive agent indicated for a variety of diseases and conditions, including allergic, dermatologic, gastrointestinal and hematologic.
The medication also enjoys the distinction of—pending approval—being the first oral steroid label in the FDA’s new physician labeling rule format. The PLR format, which went into effect June 19, requires new content, new structure and new highlights information, as compared to the former structured product labeling.