Advagraf still waiting for FDA approval
WASHINGTON Astellas says it has received a fourth approvable letter from the Food and Drug Administration for its immunosuppressant drug Advagraf, again delaying the drug’s approval.
In December 2005, the company’s U.S. subsidiary submitted an application for Advagraf for the prevention of organ rejection in kidney, liver and heart transplants.
The FDA replied with an approvable letter for liver transplantation in January 2007 to which the company responded last July.
In addition to a second approvable letter for liver transplantation, which the company said it received April 30, the FDA sent the firm two approvable letters for kidney transplantation in January 2007 and March and a not-approvable letter for heart transplantation in January 2007.
Study finds more than half of Americans regularly take prescription meds
FRANKLIN LAKES, N.J. For the first time, a majority of Americans with health insurance have some kind of chronic health condition, and young people have experienced the largest increases.
According to research released Wednesday by Medco Health Solutions that examined the prescription claims of around 2.5 million Americans, 51 percent of insured Americans took prescription drugs to treat chronic health problems in 2007. While the elderly still constitute the largest demographic such medications, nearly half of women aged 22 to 44 and a third of men in the same age bracket were also using them. Men and women in that age group experienced a 20 percent increase in use of drugs to treat chronic conditions between 2001 and 2007.
Among men in the 20 to 44 age bracket, drugs to treat hypertension and cholesterol were among the top four, showing an increase in heart disease in this group. Nearly 30 percent of children aged 19 and younger also took chronic medications, mostly to treat asthma, allergies, depression and attention deficit/hyperactivity disorder.
Avastin/Lucentis study may reverberate through industry
NORWALK, Conn. According to IMS Health, a new clinical trial that began this year by a research institute may change the relationship between payers and the pharmaceutical industry, the Financial Times reported.
The National Eye Institute has sponsored a $16 million head-to-head trial of Genentech’s drugs Avastin and Lucentis. Lucentis is approved to treat age-related macular degeneration and Avastin is used to treat cancer but, both drugs are very similar and physicians have been using Avastin off-label for AMD.
The problem with the off-label use is the cost, as a single dose of Lucentis costs $2,000 while a bottle of Avastin can be split up to cost only $40-$75 per injection.
IMS argues that if CATT, the Institute’s study, shows Avastin to be as safe and effective for AMD as Lucentis, it may pave the way for an increasing number of payers to take comparative drug studies out of the hands of the pharmaceutical companies, especially as databases of patients make it much easier to conduct such tests.
But it warns that the move may create a disincentive for companies to study such areas, and creates untested areas of who would approve Avastin for AMD following a late-stage Phase 3 clinical trial which was conducted without any of the usual early-stage testing regulators usually require.
The study is expected to conclude in 2010 and has no involvement with Genentech.