NIH to run head-to-head comparison of Lucentis and Avastin
WASHINGTON The National Institutes of Health on Friday announced that it was starting a head-to-head trial of two of Genentech’s drugs, Lucentis and Avastin, according to the Wall Street Journal.
Lucentis is approved to treat an eye disease known as we age-related macular degeneration. Avastin is approved to treat breast, metastatic colorectal and non-small cell lung cancers. But, Avastin has been prescribed off-label by physicians to treat the macular degeneration, which occurs when abnormal blood vessel growth harms or destroys part of the eye. Avastin is sold at a fraction of the cost of Lucentis.
The study, funded by the National Eye Institute, will involve 1,200 patients who will either receive a monthly Lucentis or Avastin during an initial one-year treatment period. Patients will then be broken into additional treatment groups for the second year and will be treated with either drug on a varying schedule.
The study, known as CATT, or comparison of AMD treatment trials, will be conducted at 47 clinical centers. Study results are expected in 2011.
Jury hits AstraZeneca with $215 million fine in price-inflation case
MONTGOMERY, Ala. An Alabama state court jury found AstraZeneca Pharmaceuticals at fault in inflating drug prices charged to the state’s Medicaid program, according to published reports. As a result, the company has to pay $215 million, $40 million in compensatory damages and $175 million in punitive damages.
Alabama claimed in its complaint, filed in 2005, that the companies overstated the average wholesale price of drugs, which is used to calculate Medicaid reimbursement rates to pharmacies.
AstraZeneca said the judge made numerous errors in the trial, which started Feb. 11. Those errors included barring evidence of how pharmacies manage Medicaid drug costs, according to the company.
AstraZeneca lawyer Thomas Christian told the jury in opening statements that state Medicaid officials had a complete understanding of how drug pricing worked. Once a drug was shipped to the wholesaler and then pharmacies, the company had no control over pricing, Christian said. The company plans on appealing the decision.
AstraZeneca is the first of more than 70 drugmakers sued by Alabama to go to trial. GlaxoSmithKline and Novartis Pharmaceuticals are scheduled for trial in April. Takeda Pharmaceuticals North America and Merck’s Dey unit settled pricing claims with Alabama last month for a combined $6.75 million while admitting no liability.
Prasugrel given priority review by FDA
WASHINGTON A new drug, prasugrel, manufactured by Eli Lilly and Daiichi Sankyo, has been granted a priority review by the Food and Drug Administration.
The drug is intended for the prevention of blood clots, and if approved, will be competing against Plavix, the blockbuster drug sold by Bristol-Myers Squibb Co and Sanofi-Aventis. A study conducted in November has already shown that prasugrel was 19 percent more effect than Plavix, but resulted in a higher amount of serious bleeding.
A priority view, according to published reports, means that the FDA will decide within six months whether or not to approve the drug. An approval for a drug usually takes about 10 to 12 months.
The application for prasugrel was filed on December 26, and since the news of its priority view its shares rose up nearly 3 percent. If approved, Lilly plans its drug to be brand named Effient.