Ajovy, the Second Drug Targeting CGRP, Receives FDA Approval





Late on Friday, September 14, 2018, Teva Pharmaceuticals USA, Inc, received approval for fremanezumab vfrm (Ajovy) from the United States Food and Drug Administration (FDA).

Ajovy has been approved for the preventative treatment of migraine in adults, and is the first drug targeting CGRP that is available in both quarterly and monthly dosing options.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,” said Stephen Silberstein, MD, Director, Jefferson Headache Center, Jefferson University Hospital, and lead investigator of the Phase III clinical trial program for Ajovy. “About 40 percent of people living with migraine may be appropriate candidates for preventative treatment, yet the majority of them are not treated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”

Ajovy Basics

Ajovy is a humanized monoclonal antibody that bonds to the calcitonin Gene-related Peptide (CGRP) ligand (antibody in thebody), blocking it from bonding to the CGRP receptors. It is the second drug targeting and preventing CGRP from bonding to the receptor to be approved by the FDA. The first, Aimovig, works by bonding directly to the receptor..

Impact of Migraine

As Dr. Silberstein indicated in his statement, migraine is a neurological condition that affects between 36 and 37 million people in the US alone. Migraine is a moderate to severe pain typically felt on one side of the head that is also accompanied by other neurological symptoms such as nausea; vomiting; sensitivity to light, sound, and/or smell; dizziness; and numbness and/or tingling in the affected side. 91% of people who experience migraine cannot continue to function normally during an attack.

For more information on migraines, CLICK HERE.

MoleculesThe Role of CGRP

Researchers believe that migraines are caused by the irritation of the nerves on the surface of the brain by CGRP which causes the cascade of symptoms felt during an attack. CGRP blocking drugs such as Ajovy block the binding of CGRP, which is believed to stop the pain and associated symptoms of a migraine headache attack. Drugs like Ajovy are the first drugs to address the cause of migraines, rather than just treating the symptoms. This is a huge step forward in the treatment of this disease.

For more information on CGRP drugs, CLICK HERE.

Approval Process

Ajovy was evaluated in patients with disabling migraines as both a standalone preventatives and in conjunction with oral Approval Process/Researchpreventative medications in two Phase III, placebo controlled clinical trials. Patients were evaluated over a twelve-week period of time, with most patients experiencing a significant decrease in the number of migraine days.

“This is an important day for Teva and compliments our long-standing history of helping patients living with diseases of the central nervous system,” Said Kare Schultz, President and CEO of Teva. “The approval of Ajovy helps us to continue to provide access to important medicines and to deliver on our commitments to our stakeholders – patients, employees and shareholders.”

Availability and Cost

Teva says that Ajovy, in either a single monthly subcutaneous dose of 225 mg or a quarterly, 675 mg option delivered in three 225 mg subcutaneous doses, will be available from both retail and specialty pharmacies in about two weeks. Costs/dollars

Ajovy does require a prescription by your doctor. If you are interested in trying Ajovy, now would be the time to schedule an appointment.

Teva has kept the cost of Ajovy in line with that of Aimovig. The Wholesale Acquisition Costs (WAC) of monthly doses will be $575 per month, with the quarterly option costing approximately $1725. Teva is working with commercial insurance companies on coverage for Ajovy.

Teva also have a program available to patients with commercial insurance which would make the co-pay for Ajovy as little as $0. For more information on the co-pay program, CLICK HERE.

“Today’s approval is an important step forward for Teva and the migraine community,” said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva. “Our entire organization is proud to bring this new biologic product forward at a responsible price, and we are eager to work with insurers to encourage coverage that provides full access and availability in this much-needed category.”

A Word of Warning

WarningsAs with any medication, there are some people who will experience adverse reactions to Ajovy. In fact, Ajovy is contraindicated in patients who have already experienced serious hypersensitivity reactions. Those who try Ajovy and experience hypersensitivity reactions such as rash, puritis, urticaria or other hypersensitivity reactions, are advised to discontinue use of Ajovy and immediately seek medical help.

Adverse reactions to Ajovy in clinical trials were mild to moderate, though some reactions did require treatment with corticosteroids. A few infections were also reported. The most common adverse reactions (greater than or equal to 5% of placebo) were reactions (soreness and rash) at the injection site. Reactions to Ajovy occurred from and hour to one month after the injection was given.

CLICK HERE to report any reactions or side effects to Ajovy.

The Link to Clusters

Ajovy was also involved in trials for cluster headaches. The trial for chronic cluster headaches was discontinued after it was estimated that the endpoints for the trial would not be met. Trials on episodic cluster headaches are continuing and results are expected soon.

Wrap Up

With FDA approval of Ajovy, the second drug targeting CGRP in the prevention of migraine, the options for those who suffer this disabling neurological disease are growing. The studies are promising that Teva has brought to the marketplace an effective and flexible medication in Ajovy. In clinical trials significant improvement has been seen with very little contraindication and adverse reactions.

If you are interested in trying Ajovy, you should make an appointment now with you doctor. As was the case with Aimovig, insurance approval will likely hinge on several factors including the number and severity of migraines and migraine days you are having, how long you have experienced migraine, and what previous preventative measures you have already tried.

If you have commercial insurance coverage, you should also contact Teva to enroll in the prescription co-pay program where your cost could be as little as $0. Making a call to your insurance company, if you have commercial insurance, might also be in order to determine what information your doctor will need to submit in order for them to cover Ajovy for you.

As always, I am interested in hearing from you. What are your thoughts, feelings, questions or experiences with migraine or about the new CGRP drugs, like Ajovy? Please leave them in the comments. I will happily keep the conversation going! COMMENT BELOW!


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