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Teva Reports Positive Top-Line Data for Migraine Candidate

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Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced positive top-line results from the phase IIIb FOCUS study that evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate responses to two to four classes of preventive treatments.

We remind investors that fremanezumab is marketed as Ajovy injection in the United States for prevention of chronic/episodic migraine. The drug is the first and only anti-calcitonin gene-related peptide (“CGRP”) treatment, which is approved with monthly (225 mg) and quarterly (675 mg) dosing options. FOCUS study is the first of its type to be conducted in chronic as well as episodic migraine patients. The study evaluated the efficacy, safety and tolerability of quarterly and monthly treatment with fremanezumab compared to placebo. In the study, 838 patients were enrolled. Patients treated with fremanezumab experienced highly significant reduction in the monthly average number of migraine days versus placebo (-0.6 days) over the 12-week assessment period, for both monthly and quarterly dosing regimens.

Further, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints, for both quarterly and monthly dosing regimens. 

Shares of the company have decreased 6.9% year to date compared with the industry’s decline of 17.8%.

 

Migraine has limited treatment options and anti-CGRP is a new treatment mechanism. However, Amgen (AMGN - Free Report) /Novartis’ (NVS - Free Report) Aimovig (erenumab) was approved and launched for prevention of migraine in the second quarter of 2018. Eli Lilly and Company’s (LLY - Free Report) CGRP antibody, Emgality (galcanezumab) received approval by the FDA in September for the preventive treatment of migraine in adults. 

Teva Pharmaceutical Industries Ltd. Price

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Teva currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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