Merck’s cardiovascular drug improves cholesterol levels in patients during late-stage trial
WHITEHOUSE STATION, N.J. Patients taking an investigational treatment for cardiovascular disease showed big improvements in cholesterol levels, according to late-stage clinical trial results released Wednesday.
Merck announced results of its 18-month phase-3 trial of anacetrapib in 1,623 patients with coronary heart disease. The drug showed no difference in safety compared with placebo, and 16 patients experienced cardiovascular problems –– cardiovascular death, heart attack, unstable angina or stroke –– compared with 21 taking placebo. Data were presented Wednesday at the scientific sessions of the American Heart Association and published online in the New England Journal of Medicine.
Most importantly, after 24 weeks of treatment among patients who had previously taken a statin, the drug decreased “bad” LDL cholesterol by 40% while increasing “good” HDL cholesterol by 138%.
Takeda launches GetToKnowGERD.com
NEW YORK — Drug maker Takeda Pharmaceuticals is launching a campaign to raise awareness of gastroesophageal reflux disease, the company said Tuesday.
Takeda created the website GetToKnowGERD.com to coincide with GERD Awareness Week, which takes place from Nov. 21 to 27. The company also is using the occasion to promote the GERD drug Dexilant (dexlansoprazole).
GERD is an often chronic condition characterized by frequent heartburn that affects nearly 19 million Americans, but according to an Omnibus telephone poll of 1,000 U.S. adults conducted in October, around 80% of people are not aware of how common it is.
Labopharm reviewing notification of Actavis’ approval application for generic Oletpro
LAVAL, Quebec — Generic drug maker Actavis has filed for approval of a generic version of an antidepressant made by Canada’s Labopharm, Labopharm said.
The drug maker said it received a notification stating that Actavis had applied to the Food and Drug Administration for approval of a generic version of Oletpro (trazodone hydrochloride) extended-release tablets in the 150-mg and 300-mg strengths.
Actavis’ application contained a Paragraph IV certification, a legal challenge to a Labopharm patent covering the drug, which expires in June 2020. The market exclusivity period, which prevents the FDA from approving Actavis’ version, expires in February 2013.
Labopharm said it was reviewing the letter to determine what steps to take, though under the Hatch-Waxman Act of 1984, it is allowed to file a lawsuit against Actavis to prevent the latter from marketing its generic version of the drug.