Teva Pharmaceutical Industries Ltd. has announced that the US Food and Drug Administration (FDA) has approved Ajovy (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. Teva Pharmaceuticals is headquartered in Jerusalem, Israel.
Indications: Ajovy, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options.
Dose/administration: 2 subcutaneous dosing options of Ajovy are available to administer the recommended dosage:
- 225 mg monthly, or
- 675 mg every 3 months (quarterly).
The 675 mg quarterly dosage is administered as 3 consecutive injections of 225 mg each. Dose should be administered in the abdomen, thigh, or upper arm subcutaneously.
Adverse reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.
Teva announces US approval of Ajovy (fremanezumab-vfrm) injection, the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults. [news release]. Jerusalem, Israel: Teva Pharmaceutical Industries Ltd. September 14, 2018. https://www.businesswire.com/news/home/20180914005613/en/. Accessed October 15, 2018.
This Week's Must Reads
Must Reads in FDA Actions
FDA Approves Firdapse for Rare Autoimmune Disorder, FDA news release; 2018 Nov 28
FDA Approves Ajovy for Migraine in Adults, Teva Pharmaceutical news release; 2018 Sep 14
FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6
FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23
FDA Approves Drug for Rare Peripheral Nerve Disease, FDA Web site; 2018 Aug 10