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Amgen's Migraine Drug Hits Primary Endpoint in STRIVE Study
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Amgen, Inc. (AMGN - Free Report) announced top-line data from a phase III study (STRIVE), which showed that its calcitonin gene-related peptide (CGRP) receptor, erenumab, significantly reduced monthly migraine days in patients with episodic migraine.
Erenumab is being evaluated in two phase III studies for the prevention of episodic migraine and in phase II studies for chronic migraine.
STRIVE (n=955), a global randomized, double-blind, placebo-controlled study, is the second of the phase III studies for episodic migraine to report results this year. Under STRIVE, patients were randomized to receive either placebo, or one of two erenumab doses – 70 mg or 140 mg – subcutaneously, once monthly for six months.
Patients enrolled in STRIVE were experiencing an average of 8.3 migraine days per month, at baseline. The study met the primary endpoint. Patients who were treated with either 70 mg or 140 mg erenumab experienced a statistically significant 3.2 and 3.7 days reduction, respectively, from baseline in monthly migraine days compared to a 1.8-day reduction for those receiving placebo at 24 weeks. In addition, the safety profile of erenumab was found to be similar to placebo and consistent with the previously reported studies.
Positive top-line data from the first episodic migraine study (ARISE) were presented in September. Data showed that patients, when treated with erenumab (70 mg), experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, in comparison to a 1.8-day reduction in the placebo arm at 12 weeks, thereby meeting the primary endpoint of the study.
Earlier this year, positive data from a phase II study on erenumab for the prevention of chronic migraine were also announced.
Management believes that data from the above studies can support regulatory filings which are expected in 2017.
Amgen is co-developing erenumab with Novartis AG (NVS - Free Report) . We note that several companies, including Teva Pharmaceutical Industries Limited (TEVA - Free Report) and Allergan plc among others, are developing migraine treatments targeting CGRP.
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Amgen's Migraine Drug Hits Primary Endpoint in STRIVE Study
Amgen, Inc. (AMGN - Free Report) announced top-line data from a phase III study (STRIVE), which showed that its calcitonin gene-related peptide (CGRP) receptor, erenumab, significantly reduced monthly migraine days in patients with episodic migraine.
Erenumab is being evaluated in two phase III studies for the prevention of episodic migraine and in phase II studies for chronic migraine.
STRIVE (n=955), a global randomized, double-blind, placebo-controlled study, is the second of the phase III studies for episodic migraine to report results this year. Under STRIVE, patients were randomized to receive either placebo, or one of two erenumab doses – 70 mg or 140 mg – subcutaneously, once monthly for six months.
AMGEN INC Price and Consensus
AMGEN INC Price and Consensus | AMGEN INC Quote
Patients enrolled in STRIVE were experiencing an average of 8.3 migraine days per month, at baseline. The study met the primary endpoint. Patients who were treated with either 70 mg or 140 mg erenumab experienced a statistically significant 3.2 and 3.7 days reduction, respectively, from baseline in monthly migraine days compared to a 1.8-day reduction for those receiving placebo at 24 weeks. In addition, the safety profile of erenumab was found to be similar to placebo and consistent with the previously reported studies.
Positive top-line data from the first episodic migraine study (ARISE) were presented in September. Data showed that patients, when treated with erenumab (70 mg), experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, in comparison to a 1.8-day reduction in the placebo arm at 12 weeks, thereby meeting the primary endpoint of the study.
Earlier this year, positive data from a phase II study on erenumab for the prevention of chronic migraine were also announced.
Management believes that data from the above studies can support regulatory filings which are expected in 2017.
Amgen is co-developing erenumab with Novartis AG (NVS - Free Report) . We note that several companies, including Teva Pharmaceutical Industries Limited (TEVA - Free Report) and Allergan plc among others, are developing migraine treatments targeting CGRP.
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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