Teva's MS hopeful takes another big hit in phase 3
- Teva has suspended the use of high doses of its MS drug laquinimod in two trials after eight patients suffered non-fatal cardiovascular events. The trials will continue with low dosages of the medication.
- Teva is pursuing an indication for relapsing remitting multiple sclerosis (RRMS) and primary-progressive MS.
- Teva hopes laquinimod will effectively replace Copaxone, its flagship MS product for RRMS, after it went off patent last year.
There have been numerous challenges meeting efficacy and safety endpoints for laquinimod over the last several years. However, Teva is determined to soldier on with development.
Teva is co-developing laqunimod with Active Biotech and the two firms have jointly completed five clinical trials. During this time, the development team expanded development to include a potential indication for Huntington's disease.
Laquinimod has shown real efficacy in terms of its ability to delay disability progression, as evidenced in the phase 3 ALLEGRO study. But the market has already shifted dramatically, even as some optimism persists for the long-term outlook for laquinimod.
The introduction of new oral treatments for MS, notably Biogen's Tecfidera and Novartis's Gilenya, has been a major game-changer. Generally, injectables, such as Sanofi's Lemtrada and Biogen's Tysrabi, are reserved for treatment of the most severe cases of MS.