Teva Pharmaceutical Industries Limited TEVA announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a marketing nod for its newly approved migraine injection, Ajovy (fremanezumab). Teva is looking for approval of Ajovy, its anti-calcitonin gene-related peptide (“CGRP”) medicine, for the preventive treatment of migraine in adult patients, who experience at least four migraine days per month.
Following CHMP’s positive response, a decision in the EU is expected during the first half of 2019. If approved, Ajovy will be the first and the only anti-CGRP treatment to secure a nod in the EU with monthly and quarterly dosing options for patients to follow.
The positive CHMP feedback was based on the efficacy and safety data from the HALO clinical development program, which evaluated Ajovy in two pivotal phase III studies. Data from these showed that patients administered with Ajovy experienced a significant higher reduction in migraine days as compared to placebo.
Shares of Teva have dipped 0.2% in the past year, narrower than the industry’s decline of 13.6%.
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We would like to remind investors that last September, Teva gained the FDA approval for Ajovy and immediately launched it as a preventive treatment for migraine. On third-quarter conference call, the company stated that it is seeing signs of a strong launch.
Migraine has limited treatment options and anti-CGRP is a new treatment mechanism. However, Amgen AMGN /Novartis’ NVS Aimovig (erenumab) was approved and launched for prevention of migraine during the second quarter of 2018. Eli Lilly and Company’s LLY CGRP antibody, Emgality (galcanezumab), was also unveiled in late 2018 for the precautionary therapy of migraine in adults.
Meanwhile, last December, Teva announced favorable top-line results from the phase IIIb FOCUS analysis, which evaluated the efficacy and safety of Ajovy for the preventive treatment of migraine in adults, having previously experienced inadequate responses to 2-4 classes of preventive treatments. The study examined the efficacy, safety and tolerability of quarterly and monthly treatment with Ajovy as compared to placebo.
Ajovy is also being investigated for episodic cluster headache in a phase III program and post traumatic headache in a phase II study.
Zacks Rank
Teva 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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