Dive Brief:
- 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.
Dive Insight:
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.