Teva Pharmaceutical Industries (TEVA) said Monday the US Food and Drug Administration has accepted its US affiliate Teva Pharmaceuticals' supplemental biologics license application for AJOVY to expand the indication to include the prevention of episodic migraine in certain pediatric patients.
The application was based on results from the phase 3 SPACE trial which demonstrated statistically significant improvements in reducing monthly migraine days and monthly headache days using AJOVY compared to a placebo, the company said.
Teva's share price rose more than 5% in recent premarket activity.
Price: 14.54, Change: +0.74, Percent Change: +5.36
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