FDA approves J&J HIV drug in children
TITUSVILLE, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating HIV in children.
J&J’s Janssen Therapeutics division announced Tuesday the FDA approval of Intelence (etravirine) in patients ages 6 years to younger than 18 years with HIV-1 who have taken other therapies but whose infection has become resistant to treatment. The drug already was approved for adults.
"This indication fulfills an important need in the U.S. among treatment-experienced young children and adolescents living with HIV," Janssen Therapeutics medical director David Anderson said. "This approval also expands the treatment options Intelence offers and reinforces our company’s commitment to serving the diverse needs of the HIV treatment community."
ReportersNotebook — Chain Pharmacy, 4/2/12
SUPPLIER NEWS — A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said. New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.
A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said. The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The FDA approved the drug on Jan. 30.
The companies developed the drug under a partnership started last year that resulted in a dispute between Lilly and Amylin Pharmaceuticals, with which Lilly had developed the injected Type 2 diabetes drugs Byetta (exenatide) and its long-acting version, Bydureon, which the FDA also approved on Jan. 30. Lilly and Amylin terminated their agreement in November.
The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said. Eisai said the FDA delivered a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about a regulatory application that preclude approval.
The drug maker said the FDA’s decision was due to the primary study not providing convincing evidence of safety and effectiveness for AML. The drug already is approved for treating myelodysplastic syndromes, a group of cancers that result from damage to the cells in the bone marrow that form blood cells.
Increase in Rx costs surpasses inflation rate
Increases in the prices of prescription drugs have far outpaced the rate of general inflation over the years, as increases in the prices of branded and specialty drugs have offset decreases in the prices of generics, according to a new report by AARP’s research arm.
The study, conducted by AARP’s Public Policy Institute, found that the cumulative change in drug prices from 2005 to 2009 was almost double the rate of inflation. As a result, the average annual cost of drug therapy continued to rise.
The study was based on examinations of retail prices for the 514 drugs most used by Medicare beneficiaries. In 2009, while the rate of general inflation was -0.3%, the drugs increased in price by an average of 4.8%. Branded drugs increased in price by 8.3%, while specialty drugs rose by 8.9% and generic drugs decreased by 7.8%.
“For the people who rely on these drugs, such relentless price increases have serious implications,” AARP SVP public strategy Cheryl Matheis said. “Despite price reductions for generics, it’s evident that the considerable increases in brand-name and specialty drug prices are still leaving Americans with overall costs that are growing far faster than the rate of inflation.”
The report found that the “marked” decreases in prices of generic drugs between 2005 and 2007 dropped the rate of increase to slightly below the rate of general inflation for almost six years, but since 2008, continued growth in specialty and branded drugs have “more than offset” the lower costs of generics. The report called the finding striking because generics already had lower prices and represented slightly more than one-fifth of total drug expenditures by Medicare Part D plans in 2006.
For the 469 drugs on the market since the end of 2004, prices increased by 25.6% from 2005 to 2009, while the general inflation rate was 13.3%. Consumers taking drugs to treat chronic diseases found that their average annual cost increased from $2,160 to $3,168.
The report received praise from the country’s largest trade group representing generic drug manufacturers. “The AARP report offers an important reminder of the vital role generic medicines play in reducing costs throughout the healthcare system, while providing patients access to safe, effective and affordable treatment options,” Generic Pharmaceutical Association president and CEO Ralph Neas said. “With evidence of the dramatic savings generic drugs can achieve becoming more prevalent every day, we urge lawmakers to ensure that efforts to reduce spending do not in any way dampen the availability and use of lifesaving and life-enhancing generic medicines. The future of the U.S. healthcare system and the national economy depend on it.”