Arena, Eisai receive complete response letter for lorcaserin
SAN DIEGO The Food and Drug Administration declined to approve a regulatory approval application from Arena Pharmaceuticals and Eisai for a drug to treat obesity, the two companies said Saturday.
The FDA issued a complete response letter for the drug lorcaserin, designed for weight management and weight loss in patients who are overweight or obese and have at least one co-morbid condition. The FDA issues a complete response letter when it finishes reviewing an approval application, but issues remain that preclude final approval.
The FDA told the companies that it found problems regarding tumors in the mammary glands of rats receiving the drug and issues surrounding the efficacy of the drug in some patients.
“This is an important step for us toward the FDA’s approval of lorcaserin,” Arena president and CEO Jack Lief said. “While the complete response letter provides us with recommendations from the agency, we intend to meet with the FDA to obtain further clarity on the approval path and timeline.”
AP poll finds Americans evenly divided on impact, benefits of health-reform law
WASHINGTON Seven months after President Obama signed the massive health-reform bill into law, Americans remain deeply divided over the controversial overhaul and its potential benefits, a new poll from the Associated Press and the GfK Group revealed.
In a mid-October survey of 1,501 adults, AP-Gfk found the nation evenly split over whether the law should be overturned or made even stronger. But also significant is the fact that only 15% of Americans would leave the health-reform law — thus far the key legislative accomplishment of the Obama administration — as it currently stands.
Among the 846 poll respondents who said they likely would vote in the November congressional elections, 37% said the law should be completely repealed, according to AP. Not surprisingly, opposition among Tea Party supporters was strongest, with more than 70% of respondents who describe themselves as Tea Party enthusiasts saying they would scrap health reform.
Despite the opposition, 36% of those polled had a very different view, telling surveyors “they want to revise the law so it does more to change the healthcare system,” the news service reported Friday. That means “Tea Party enthusiasm for repeal has failed to catch on with other groups,” according to AP, “which may be a problem for Republicans vowing to strike down Obama’s signature accomplishment if they gain control of Congress in the Nov. 2 elections.”
Among the top concerns about the new law expressed by survey respondents: a requirement that most Americans carry some type of public or private health insurance, beginning in 2014. Some told researchers the law does little to address rising health spending.
Older Americans also expressed concern over the plan to help fund the health overhaul in part by cutting spending for Medicare. Some poll respondents also asserted the need for a public-health plan option to compete with private insurers and to help hold down costs, a plan that was eliminated from the original bill before its passage in Congress.
Support for health reform is strongest among women and younger voters, according to AP.
Diamyd Medical to divide business
STOCKHOLM Diamyd Medical will split its business into separate divisions for pain relief and diabetes, the drug maker said Friday.
The Swedish company said its diabetes business would consist mostly of the investigational antigen-based drug Diamyd, for Type 1 diabetes, while the pain business would comprise of development projects using its nerve-targeting drug delivery system platform to administer drugs directly to the nervous system to treat pain.
The company will begin the division process during the new 2010-2011 fiscal year.