The Ministry of Food and Drug Safety (MFDS) announced Monday that it has given Lilly’s Emgality (Ingredient: galcanezumab-gnlm), a migraine prevention treatment, an orphan drug status.
The drug, which patients can self-administer through a subcutaneous injection once a month, blocks migraine attacks by binding to the calcitonin gene-related peptide. The ministry has designated it as the orphan drug treating episodic cluster headaches.
The treatment also received approval from the U.S. Food and Drug Administration as a once-monthly migraine prevention injection for adults in September last year.
Lilly demonstrated the efficacy and safety of Emgality through three clinical trials -- EVOLVE-1, EVOLVE-2 and REGAIN -- in migraine patients.
EVOLVE-1 and EVOLVE-2 evaluated the safety and efficacy of the treatment against placebo for six months in 1,773 adult patients with migraine symptoms less than 15 days per month. REGAIN studied 1,113 patients with chronic migraine with a headache of more than 15 days per month for three months against placebo.
After an initial dose of 240 mg, patients received either a placebo, 120 mg or 240 mg in all three studies.
As a result, the treatment proved to be significantly superior to placebo in preventing migraine. The most common side effects were injection site reaction and pain.