FDA Approves Fremanezumab Autoinjector

January 30, 2020

Teva announced that the Ajovy autoinjector is expected to be available to patients in the coming months.

Brendan O'Grady

The FDA has approved an autoinjector for the delivery of fremanezumab (Ajovy; Teva Pharmaceuticals), an anti-calcitonin gene-related peptide (anti-CGRP) approved for the prevention of migraine in adults.

“The approval of the Ajovy autoinjector is another important step forward for Teva and the migraine community. Ajovy is the only FDA-approved anti-CGRP that offers the flexibility of quarterly (675 mg) or monthly (225 mg) dosing options, and we are pleased that patients and their healthcare providers will be able to decide if an autoinjector is the right administration option for their needs,” said Brendan O’Grady, executive Vice President, North America Commercial, Teva, in a statement.

The approval now evens the playing field between the anti-CGRP agents on the market, as Teva’s Ajovy, Amgen’s Aimovig, and Eli Lilly’s Emgality are all available for administration via autoinjector, which may be preferred among patients.

In September 2018, the FDA approved fremanezumab for the prevention of migraine in adults. The drug was originally made available for administration via a prefilled syringe indicated for one-time use.

Patients who use the prefilled syringe of fremanezumab must let the drug sit at room temperature for at least 30 minutes, cannot inject intravenously, and cannot reuse.

The drug’s FDA approval was based off data from 2 studies in the phase 3 HALO clinical trial program. In those trials, investigators observed that fremanezumab reduced monthly migraines by >50% in roughly 45% of patients with episodic migraine and in about 40% of patients with chronic migraine.

At the time, fremanezumab was the second approved member of the anti-CGRP class of migraine drugs, following erenumab (Aimovig; Amgen).

The first clinical study revealed an average reduction of 4.3+0.3 headache days per month in those who received fremanezumab quarterly. The data showed greater improvement in those who received it monthly, reducing the average number of headache days per month by 4.6+0.3 compared with 2.5+0.3 in the placebo group.

Injection site reactions were among the most common adverse events (>5% and greater than placebo) recorded in the clinical trials. Other hypersensitivity reactions observed include pruritus, rash, and urticaria. Most hypersensitivity reactions were mild to moderate, but some led to discontinuation. Teva advises that those who experience a consistent hypersensitivity reaction to consider discontinuing and switch to a more appropriate therapy.

Teva did not announce a specific date of availability for the autoinjector, but indicated that it will be available in the coming months.

REFERENCE:

Teva announces FDA approval of ajovy (fremanezumab-vfrm) injection autoinjector [news release]. Parsippany, NJ: Teva Pharmaceuticals. January 28, 2020. businesswire.com/news/home/20200128005810/en. Accessed January 28, 2020.