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The multinational, randomized, double-blind placebo-controlled study is being conducted in patients with relapsing-remitting multiple sclerosis (RRMS). Two doses of laquinimod (0.6 mg and 1.2 mg) will be evaluated in the study with the primary endpoint being confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).
Laquinimod has been evaluated in two other phase III trials (ALLEGRO and BRAVO) earlier. The candidate is also being studied for Crohn’s disease and lupus.
The successful development and launch of laquinimod would help strengthen Teva’s multiple sclerosis drug portfolio. Being an oral formulation, laquinimod could provide an advantage over therapies that require injection or infusion.
Teva already has a multiple sclerosis product in its portfolio – Copaxone. Copaxone is approved for the reduction of the frequency of relapses in RRMS, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
We are pleased with Teva’s efforts to expand its multiple sclerosis franchise. The multiple sclerosis market represents significant commercial potential. The disease is estimated to affect more than 400,000 people in the US. Worldwide, it is estimated that more than two million people may be suffering from multiple sclerosis.
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