Teva Pharmaceutical Industries and partner Active Biotech say they are not giving up on their multiple sclerosis pill Nerventra despite another rejection from advisors to the European Medicines Agency.
The EMA's Committee for Medicinal Products for Human Use (CHMP) has confirmed its opinion from January to recommend against approval for Nerventra (laquinimod). Teva and Active had appealed the decision against the treatment for relapsing-remitting MS but the second review has come up negative again.
Teva chief scientific officer Michael Hayden said that "we are disappointed with the outcome of the re-examination and will be working with the EMA to make Nerventra available to MS patients in the EU". Unlike the CHMP, he added that the companies believe the drug has a favourable risk-benefit profile "and the potential to fulfil an unmet need for a treatment that decreases disability progression, and protects against brain volume loss, two important goals in the management of MS".
Following two late-stage studies, Teva is conducting a third Phase III trial, CONCERTO, evaluating two doses of Nerventra (0.6mg and 1.2mg) in 2,100 patients for up to 24 months. The primary endpoint will be time to confirmed disability progression, the largest MS clinical trial to have this as its goal.
In addition, Teva is investigating Nerventra in progressive forms of MS and the first trial for this indication is planned to be initiated soon.