Teva meddelar att Ajovy (fremanezumab-vfrm) nu är godkänd för prevention av migrän hos vuxna på den Amerikanska marknaden

Teva meddelar att Ajovy (femaezumab-vfrm) nu är godkänd för prevention av migrän hos vuxna
Teva meddelade idag att FDA har godkänt AJOVY (fremanezumab-vfrm) injektion för prevention av migrän hos vuxna. AJOVY, är en humaniserad monoklonal antikropp som binder till och blockerar CGRP (calcitonin gene-related peptide) och det är den första och enda anti-CGRP behandlingen med både kvartalsvis och månatlig dosering för prevention av migrän på den amerikanska marknaden.

Teva announced today hat the U.S. Food and Drug Administration (FDA) has approved AJOVYTM (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. 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.

“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 at Thomas 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 preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”

AJOVY was evaluated in two Phase III, placebo-controlled clinical trials that enrolled patients with disabling migraine and was studied as both a stand-alone preventive treatment and in combination with oral preventive treatments. In these trials, patients experienced a reduction in monthly migraine days during a 12-week period. The most common adverse reactions (≥5 percent and greater than placebo) were injection site reactions.

“This is an important day for Teva and complements our long-standing history of helping patients living with diseases of the central nervous system,” said Kåre 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 commitment to our key stakeholders – patients, employees and shareholders.”

“With limited availability of preventive treatment options, AJOVY provides physicians with an important new option for their patients,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D at Teva. “This approval furthers our ongoing commitment and experience in neurological conditions like migraine.”

The U.S. Wholesale Acquisition Cost (WAC) of AJOVY is $575 per monthly dose and $1,725 per quarterly dose. AJOVY will be available through retail and specialty pharmacies in approximately two weeks. There is a savings offer for AJOVY. Commercially insured patients may pay as little as $0 on prescriptions for AJOVY until the offer expires. Teva Shared Solutions® is available to provide support services for patients and offices. Visit AJOVY.com to learn more.

“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.”

About AJOVYTM

AJOVY is indicated for the preventive treatment of migraine in adults. AJOVY is available as a 225 mg/1.5mL single dose injection in a prefilled syringe with two dosing options – 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), administered as three subcutaneous injections. AJOVY can be administered in office by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.

IMPORTANT SAFETY INFORMATION

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

Please click here for full Prescribing Information for AJOVYTM (fremanezumab-vfrm) injection.