Teva’s AJOVY® Receives EU Approval as First and Only Anti-CGRP Migraine Preventive with Monthly and Quarterly Dosing Options

April 02, 2019 News /BioValleyBIOON/ -- Israeli pharmaceutical giant Teva recently announced that the European Commission (EC) has approved Ajovy (fremanezumab) 225 mg pre-filled syringes for injection for the preventive treatment of migraine in adult patients who experience migraine on at least four days per month. Ajovy is the first and only anti-CGRP therapy approved in both the European Union and the United States with both monthly and quarterly (every three months) dosing regimens.

Richard Daniell, Executive Vice President of Commercial Operations for Teva Europe, stated, “We are delighted with the EC approval, which marks another significant milestone for both our company and the broader migraine community. We aim to expand the availability of Ajovy across the European Union, enabling eligible patients to benefit from the flexible dosing options of Ajovy, administered subcutaneously either once monthly or once every three months.”

The approval of Ajovy was based on data from the Phase III clinical development program, HALO. This program included two pivotal Phase III clinical studies (HALO-EM and HALO-CM) that enrolled more than 2,000 patients with episodic migraine (EM) and chronic migraine (CM), evaluating the efficacy and safety of Ajovy administered via subcutaneous injection once monthly or once quarterly. Data from this program demonstrated that, compared with placebo, both the once-monthly and once-quarterly subcutaneous injection regimens of Ajovy achieved clinically and statistically significant improvements across all endpoints and in all prespecified analyses: significant reductions in monthly migraine days and headache days, significant decreases in acute medication use and disability, and significant improvements in quality of life. Regarding safety, the most common adverse events were injection-site induration, erythema, and pruritus, with similar incidence rates observed in the placebo and Ajovy treatment groups.

Migraine is a common chronic neurovascular disorder characterized by recurrent episodes of severe headache, typically unilateral, often accompanied by nausea, vomiting, phonophobia, photophobia, and visual disturbances; symptoms can be alleviated in a quiet environment with rest.

Migraine is the third most common disease and the sixth leading cause of disability worldwide, with more than 1 billion people affected globally. In Europe, there are over 50 million migraine patients, and the total annual healthcare expenditure for migraine reaches €111 billion. Currently, no medication can cure migraine. The World Health Organization (WHO) has designated migraine as one of the 20 most disabling diseases. Compared with the general population, individuals with migraine are more likely to experience depression, anxiety, sleep disorders, other pain conditions, and fatigue.

In addition to the three antibody drugs approved as mentioned above, Alder’sMonoclonal Antibody DrugsEptinezumab (administered via intravenous infusion once every three months) had its application submitted in the United States at the end of February this year, with response rates reaching as high as 100% in certain patients.

In addition, several companies are developing oral CGRP inhibitors. In early March this year, Allergan submitted a marketing application in the United States for the oral drug ubrogepant for the acute treatment of migraine (with or without aura).FDAA final review decision will be made in the fourth quarter of 2019. If approved, ubrogepant will become the first oral CGRP receptor antagonist for the acute treatment of migraine (with or without aura) in the U.S. market in the past 25 years.

However, in mid-March this year, Biohaven Pharmaceuticals splurged $105 million to purchase a Priority Review Voucher (PRV) from GW Pharmaceuticals and plans to submit it in the second quarter of this year.FDAA New Drug Application (NDA) has been submitted for the oral CGRP receptor antagonist Zydis (rimegepant) orally disintegrating tablets. This Priority Review Voucher (PRV) will be applied to the NDA review, shortening the standard 10-month review period by four months and enabling completion of the review within six months.

This means that Allergan and Biohaven have engaged in direct competition for the title of “first oral CGRP receptor antagonist.” It remains to be seen who will emerge victorious. (Bioon.com)

Original Source:Teva’s AJOVY® Receives EU Approval Offering Patients the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Prophylaxis of Migraine in Adults