Arena announces successful lorcaserin safety review
SAN DIEGO Arena Pharmaceuticals announced this week that the results of a 12-month safety review of its obesity drug lorcaserin has found no heart valve problems and that the drug was safe for use, according to published reports.
The drug blocks appetite signals in the brain. There have been concerns though that drug may have a fatal side effect, heart valve damage. Redux, lorcaserin’s parent drug, manufactured by Wyeth, was pulled off the market because it was linked to heart valve damage. But, the difference between the drugs is that Redux was hitting too many biological receptors on top of the one that reduces appetite.
The Echocardiographic Data Safety Monitoring Board had monitored 3,200 clinical trial participants using the drug. “This critical milestone assessing month-12 echocardiographic data strongly supports lorcaserin’s cardiovascular safety profile,” Arena chief executive officer Jack Lief said in a statement.
The safety board will not meet again on this drug, but Arena will continue to collect heart safety data after 18 months and 24 months of the two-year study known as the Bloom trial. Patients have begun enrollment in the Bloom trial and will be for one year and include people previously diagnosed with a heart valve disorder. A third trial for the drug, for people with Type 2 diabetes, is now under way.
Final data from the trials is expected in 2009, which the company hopes will help it to file an application with the Food and Drug Administration before the end of 2009.
QLT to sell off Aczone following FDA decision
VANCOUVER, Canada QLT has announced that it will proceed with its plan to sell its topical acne treatment Aczone after the Food and Drug Administration removed key blood monitoring requirements for the treatment, according to Reuters.
The company is selling the drug as part of a multi-step process to return it to its core business of treating eye diseases. Recently the company had been delving into acne and prostate cancer treatments.
Already several companies have expressed interest in Aczone and QLT predicts the drug will be sold within the next quarter or two.
Safeway offers Shingles vaccination
PLEASANTON, Calif. Safeway is offering immunization against Shingles, a disease that commonly affects people over 50 or people with compromised immune systems, at 700 pharmacies in the states of Ark., Calif., Colo., Del., Hawaii, Ind., Ill., Mont., Neb., Nev., Ore., Pa., Texas, Va. ,W.Va. and Wash. The vaccine will be provided on a walk-in basis at in-store pharmacies.
“The only way to prevent against contracting this debilitating disease is to get a single shot. By administering vaccines on site, Safeway is making it easy for anyone to protect themselves,” said Dave Fong, Safeway senior vice president of pharmacy. “Receiving a shingles vaccination is as easy as stopping at the pharmacy during your regular shopping trip.”
Safeway also offers full-service adult and adolescent immunization services for the prevention of such ailments as tetanus, hepatitis, pneumococcal, meningococcal and more.