 |
| Teva R&D Chief Michael Hayden |
Teva's ($TEVA) $4-billion-a-year multiple sclerosis treatment Copaxone is slated to lose patent protection next year, and the Israeli drugmaker is struggling to move the needle on its planned replacement, enduring another rejection from European reviewers.
The continent's Committee for Medicinal Products for Human Use (CHMP) declined to recommend Teva's laquinimod for approval, confirming a negative opinion handed down in January. The drug, which Teva hopes to market as Nerventra, is an oral treatment for relapsing-remitting MS, developed alongside partner Active Biotech.
Despite the second rejection, Teva said it has no plans to give up on the treatment, plotting to review CHMP's feedback and retool for another application.
"We are disappointed with the outcome of the re-examination and will be working with the EMA to make Nerventra available to multiple sclerosis patients in the EU," Teva R&D boss Michael Hayden said in a statement.
In its first rejection of the drug, CHMP highlighted safety risks that cropped up in animal studies and weren't quelled by later human trials, pointing out that exposure to laquinimod was tied to a higher occurrence of cancers and some dangers for pregnant women. On the efficacy side, the committee was satisfied with the treatment's ability to slow the progression of MS-related disability but unimpressed with its effect on relapses.
Laquinimod has endured two Phase III missteps on its way to regulatory trouble, failing to significantly reduce relapse rates in MS patients. Teva is now in the midst of a third late-stage trial, dubbed CONCERTO, studying the treatment's effects on disability progression. Data from that study will likely support Teva's second go at EU approval, and the company has said it expects to win U.S. approval by 2018.
- read the statement