Investing In New Indications Or New Compounds
7 CommentsBy Ed Silverman // June 30th, 2008 // 8:03 am
Take a close look at the many uses for Lilly’s Cymbalta and you could be excused for thinking the drug is a magic pill - the med is approved for treating depression, anxiety and fibromyalgia. In Europe, Cymbalta is taken for treating stress urinary incontinence. Lilly has asked the FDA to approve Cymbalta for chronic knee and low back pain, and is also testing the pill for combating chronic fatigue.
Cymbalta is an example of how drugmakers are pushing hard to find every possible use for their existing meds, writes The Indianapolis Star, in an effort to shore up revenue at a time when successfully developing and winning approval to sell new meds has become harder. Lilly, in fact, hasn’t launched a new drug for humans in three years, the paper notes.
Lilly, of course, argues its researchers are working furiously to develop new drugs for a wide array of diseases, including cancer and multiple sclerosis. In May, the company dedicated the final phase of its $1 billion biotech complex, where scientists will research the next generation of biopharmaceuticals for such conditions as diabetes and Alzheimer’s disease, the Star writes.
Whether Lilly can launch promising new drugs before losing patents on existing top sellers is unclear, the paper continues, noting that several of late-stage drugs have been shelved, including an inhaled insulin and a drug for treating eye diseases, were shelved in the past year. And last week, the FDA delayed its most critical experimental drug, the Prasugrel a blood thinner.
So is the quest for multiple indications a savvy move or a sign of a drugmaker running scared? Maybe both.
“This may speak to the desperation of companies to eke out any and all possible indications from existing drugs, rather than invest big bucks in the search for truly novel entities,” Daniel Carlat, a Massachusetts psychiatrist and frequent industry critic, tells the paper.
But Kevin Outterson, director of the health law program at the Boston University School of Law thinks “it’s kind of remarkable that some drugs can be effective for many different things. There’s nothing wrong at all with a company going through the studies and showing the FDA there’s another thing the drug can be used for, and getting it added to the label.”
“From a business point of view, it’s a great thing,” Les Funtleyder, an analyst for Miller Tabak, tells the Star. “If you have the asset, you might as well use it. But scientifically and medically, it depends, because the farther you move a drug away from its original indication, and the wider the population you have taking a drug, the greater the chance some rare side effect will pop up.”
Atlex
In addition to the reasons cited in the article, additional “approved” uses lessen the chance that a company gets accused of off-label promotion.
pharma PR hack
i think it has less to do with off-label marketing and more to do with reimbursement. Cymbalta’s expanded patent label indications are all in very crowded classes where both insurance and Medicare would be likely to pay for off-label use of it without the physician jumping through more hoops than they would like.
Atlex
Pharma PR Hack,
The sardonic edge to my comment may have gotten lost. I agree that part of it has to do with reimbursement from commercial payers. Of course, in Part D Medicare (ie, CMS doesn’t make individual reimbursement decisions; that, too, is done through plans. Then, again, an approval probably won’t make a huge reimbursement difference; plans will still likely push generic treatments, even those without FDA approval, first in order to save costs.
Atlex
Dan
What’s next? Cymbalta for pruritis? Flatulence? Bad dreams? How can people believe this stuff?
Jack2
Isn’t this exactly what we (as a society) want?
HCPs can use drugs off-label but companies cannot promote off-label. This rule gives companies an incentive (aka forces them) to prove to FDA the drug works in a particular indication, and it gives patients the increased assurance of FDA approval.
The system’s working.
qetzal
Ditto what Jack2 said.
As for Dan’s question, people can believe ‘this stuff’ because Lilly did the randomized controlled blinded trials to support the claims. A quick look at the Clinical Studies section of the current package insert described 5 different studies in major depressive disorder (1592 total patients), 3 different studies in generalized anxiety disorder (1163 pts), 2 different studies in diabetic peripheral neuropathic pain (791 pts), and 2 different studies in fibromyalgia (874 pts).
It’s funny, in a sad way, how some people will put a negative spin on anything pharma does. If pharma doesn’t do studies on secondary indications, they’re unfairly profiting from off-label use. Evil! If they do the studies to gain approval for additional indications, they’re just trying to “eke out any and all possible indications from existing drugs, rather than invest big bucks in the search for truly novel entities.” Evil!
Reminds me of a certain fable about a man and his son trying to get their donkey to market….
Charlotte
I am happy to put a negative spin on everything Pharma does. Pharma earns every bit of it.