Teva Pharmaceutical Industries Ltd. TEVA announced that its anti-calcitonin gene-related peptide (“CGRP”) injection, Ajovy, was granted marketing approval by the European Commission for prophylaxis of migraine in adult patients who experience at least four migraine days per month.
With the approval, Ajovy becomes 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 approval was expected as in February, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion, recommending approval of Ajovy
This generic drugmaker’s shares have risen 1.9% this year so far compared with the industry’s increase of 9.6%.
Ajovy (fremanezumab), for prevention of chronic/episodic migraine, was approved by the FDA in September last year. Regarding its launch uptake in the United States, Teva said, on the fourth-quarter conference call in February, that Ajovy has been performing strongly, enjoying growing demand due to its flexible dosing options - quarterly and monthly. Teva said that Ajovy has captured around 30% of new to brand patients. Ajovy recorded sales of $3 million in 2018. On the call, the company guided sales of approximately $150 million in the United States in 2019. With the approval in Europe, sales of Ajovy should be higher.
However, Ajovy faces intense competition from Amgen AMGN/Novartis NVS and Lilly’s LLY CGRPs, Aimovig and Emgality, respectively. Both were also approved by the FDA in mid-2018. Both are also approved in EU.
Fremanezumab is also being evaluated in a late-stage study for episodic cluster headache and in a mid-stage study for post traumatic headache. Teva is optimistic that Ajovy could emerge as significant contributor to its long-term sales growth.
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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