Teva Pharmaceuticals Posts Positive Phase 3 Results In Migraine Study

Teva Pharmaceuticals (TEVAannounced positive phase 3 results for its migraine study. The drug that was tested in the phase 3 trial in patients with migraine is known as fremanezumab. With the positive phase 3 results, the company is looking to submit the Biologics License Application — BLA — to the FDA . The phase 3 trial was known as the HALO study, and recruited a total of 1,130 patients.

The data showed that patients treated with fremanezumab saw a statistically significant reduction in the number of monthly headache days when put up against the placebo compound. These results were evaluated over a 12-week period after the first dose given. In addition, all patients that took the drug saw a statistical significance compared to placebo on all secondary endpoints as well.

These secondary endpoints include: Disability, response rate, onset of efficacy, and efficacy as monotherapy. Detailed results of the HALO study are expected to be shown at future medical conference. With positive results on hand, Teva expects to submit a BLA to the FDA by the end of this year. One thing to note is that if it is approved, it will be for patients suffering from chronic migraines. Teva has another phase 3 study in Episodic Migraine to be announced in the next few weeks.

Disclosure: No position in any stocks mentioned

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