Teva Slapped by FDA for Copaxone Promo

Teva Slapped by FDA for Copaxone Promo

March 19th, 2012 // 3:33 pm @ jmpickett

Source: Pharmalot

Nothing like a little exaggeration to quickly attract the wrath of the FDA. And this is what Teva Pharmaceuticals did with both a panel display at the recent American Academy of Neurology about its Copaxone multiple sclerosis treatment and a ‘Team Copaxone’ web site that the drugmaker designed to promote the medication.

In a letter last week the FDA Office of Prescription Drug Promotion scolded Teva for developing materials that were false and misleading, causing “violations (that) are concerning from a public health perspective, because they suggest that Copaxone is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience.”

To wit, the panel that Teva displayed at the AAN meeting boasted that Copaxone, which is approved for reducing the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis, has demonstrated 20 years of proven safety, show results after an average of 22 years with RRMS, and that Expanded Disability Status Scale scores remained stable after an average of 15 years on therapy.

But there was a problem – the FDA noted the claims “misleadingly overstate the safety and efficacy” because the clinical studies section of the product labeling “only includes data for up to three years in duration.” Meanwhile, the AAN exhibit panels refer to open-label extension studies, but neither of these “constitute substantial evidence to support” the claims, the FDA wrote.

The agency also expressed concern that the AAN panel suggested Copaxone is safer and more effective than other meds because no initial routine monitoring is required or recommended, but the drugmaker does not have head-to-head data to support the contention.

teva-copaxone-patients-2There was more. The Teva web site cites patients named David Kyle and Karen Stewart, both of whom showed impressive improvements in functioning after being treated with Copaxone. But the claims were considered misleading by implying the drug reverses disability and enables patients to lead active lifestyles, return to work, accomplish great athletic feats and “live the life they’ve dreamed.”

For instance, before treatment, “Karen Stewart” was constantly feeling fatigue, was unable to walk unassisted, and was forced to leave her job. After treatment, she returned to work as a nurse and walked 22 marathons. As for “David Kyle,” he was partially paralyzed and barely had enough energy to work half a day prior to Copaxone, the FDA notes. After Copaxone, he was able to compete and win national and international triathlons for the physically challenged.

“While these statements may be an accurate reflection of these patient experiences, the patient testimonials misleadingly broaden the indication and overstate the efficacy of Copaxone. As described in the Background section, Copaxone has demonstrated efficacy in decreasing the frequency of relapses in patients with RRMS. However, Copaxone is not indicated for slowing, preventing or reversing physical disability associated with RRMS,” the FDA warns Teva.

The overall impression troubled the FDA, because the agency believes the web sites suggest the drug is approved to treat all types of MS, but is not approved for slowing the progression of disability of the disease. Compounding the problem – the web sites failed to include any risk info in the body of the web pages. There are links to important safety info and the product labeling, but “these links do not mitigate the misleading omission of risk information from the body of each of these webpages.”