GSK agrees to amend black-box warning on Avandia per FDA
WASHINGTON The Food and Drug Administration announced today that GlaxoSmithKline has agreed to add new information to the existing black-boxed warning on its Type 2 diabetes drug Avandia, warning of the drug’s potential for increased risk of heart attacks.
In August, the agency had added warnings that Avandia, Actos and drugs in combination with such medications as Avandamet and Actoplus Met would receive a new warning about a risk of heart failure.
Now, as then, the agency is stating that the medication will stay on the market, but should be closely monitored by a physician.
The FDA has also concluded that, as of now, there is not enough evidence to indicate that the risks of heart attacks or death are different between Avandia and other Type 2 diabetes drugs. As a result, the FDA has asked GlaxoSmithKline to conduct a new long-term study, which the company has agreed to take part in, to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent.
The new warning will state the following:
“A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”
The FDA stated that it does plan on conducting these studies with other Type 2 diabetes medications such as Actos, which is manufactured by Takeda.
Cephalon submits application to FDA for supplemental uses of Fentora
FRAZER, Pa. Cephalon has submitted a supplemental application to the Food and Drug Administration to market its cancer drug Fentora as a “breakthrough pain” drug that would treat chronic pain conditions that could include lower back and neuropathic pain, according to the Philadelphia Business Journal.
Breakthrough pain is characterized as pain that is rapid on its onset and moderate-to-severe in intensity and relatively short in duration. If the application is approved, Fentora would also be indicated for breakthrough pain in chronic pain conditions experienced by opiod-tolerant patients.
In September, the FDA and Cephalon issued warnings to patients and doctors alerting them of the potential fatal risk factors associated with improper use of Fentora in such cases as patients using them to treat migraines or other types of short-term pain. Cephalon is also working with the FDA to update the package insert of the drug to include revised patient selection criteria and dosing instructions.
Reverse-payment bill held up in Congress by pharmaceutical lobbying
WASHINGTON Legislation aimed at speeding up the availability of cheaper generic drugs has stalled in Congress due to major lobbying by the drug industry, according to the Associated Press.
The Senate bill would ban most reverse payments, which occur when a brand-name company pays a generic manufacturer to delay the introduction of a drug.
An Associated Press review of lobbying reports, from July 1, 2006, through June 30, 2007, found that $38.8 million was spent by at least a dozen generic and brand-name companies and their trade associations on issues including the Senate legislation.
More than half of those expenses were piled up by the Pharmaceutical Research & Manufacturers of America, which represents brand-name drug companies. PhRMA spent $19.5 million in the 12-month period ended June 30 on in-house lobbying expenses, an increase of about $3 million over the previous 12-month period.
And the Generic Pharmaceutical Association reported lobbying expenses of around $420,000 for the first six months of this year. The remaining $19 million was spent by a variety of drug companies, including Bayer, Schering-Plough, Pfizer and Teva Pharmaceuticals.
“Lobbyists have a lot of influence in Washington,” said the bill’s sponsor, Sen. Herb Kohl, D-Wis., who chairs the Senate Judiciary subcommittee on antitrust, competition policy and consumer rights. “If we can just get this to a vote, it will be pretty hard for people to vote against it. A vote against this is a vote against consumers.”