Fremanezumab-VFRM

FDA approves single-dose AJOVY® (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents aged 6-17 who weigh 45 kilograms or more, offering a long-awaited monthly treatment option with in-office or at-home administration1 AJOVY expands access across age groups as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for pediatric episodic migraine prevention and migraine prevention in adults1 This approval marks an important step in expanding the impact of AJOVY beyond adults since its U.S. approval in 2018, and underscores Teva’s ongoing efforts to advance and address neurological challenges2 Aug. 06, 2025 -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today that the U.S. Food and Drug Administration (FDA) has approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. With this approval, AJOVY becomes the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of episodic migraine in pediatric patients and migraine in adults, marking a meaningful advancement in expanding preventive treatment options for those living with migraine. Preventative treatment can help reduce the frequency of migraine attacks, helping children and adolescents to better manage the condition day-to-day. AJOVY is administered once a month and available for in-office or at home use, offering a treatment option that is intended to support adherence and reduce treatment burden for families.1 “Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,” said Chris Fox, Executive Vice President, U.S. Commercial and Innovative Franchise Lead and Head of Global Marketing Business at Teva. “With this FDA approval, AJOVY now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.” 1 in 10 children and adolescents in the U.S. suffer from migraine, one of the most common and disabling neurological conditions.3 Despite its widespread prevalence, pediatric migraine is often underrecognized and undertreated, contributing to missed school days, difficulties with schoolwork, and disrupted social activities.4 "Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being," said Dr. Jennifer McVige, MD, MA, Pediatric Neurologist at the DENT Neurologic Institute. “Having an FDA-approved treatment like AJOVY offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition.” Building on its established success in adult patients since its U.S. approval in 2018, this expanded indication strengthens Teva’s commitment to broadening access to neuroscience therapies across age groups.2 AJOVY continues to demonstrate efficacy in addressing the underlying biology of migraine and now provides a treatment pathway for a patient population with historically limited preventive options. Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks.5 Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.3 AJOVY is indicated for preventive treatment of migraine in adults and episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. The content above comes from the network. if any infringement, please contact us to modify.

More than 50% of Teva’s U.S. products—including its lead drug Austedo—are manufactured locally across eight production sites, the company's CFO, Eli Kalif, said Wednesday. As more drugmakers begin to report second-quarter earnings against the backdrop of the first material pharmaceutical tariff reveal from the Trump administration, Teva Pharmaceuticals isn’t sweating the situation.The Israel-based generics and innovative medicines hybrid has “absorbed the already confirmed tariffs into our 2025 guidance,” Teva’s CFO, Eli Kalif, said on a call with analysts Wednesday.More than 50% of Teva’s U.S. products—including its lead drug Austedo—are manufactured locally across eight production sites, Kalif pointed out. Further, the company has “very limited exposures” in India and China, with Kalif attributing Teva’s lack of reliance on the latter country to the closure of its API business there four years back.“All in all, when we are looking at our supply chain, our ability to actually build inventory and to manage our manufacturing steps, we don’t see here, currently, any meaningful impact for the short term,” Kalif said. The CFO’s comments came after pharmaceutical import tariffs finally surfaced in a new trade deal struck between the U.S. and the European Union (EU) on Sunday. Under the current terms of the deal, the tariff rate stands at 15% for pharmaceutical imports—and those of many other goods—entering the U.S. from Europe.Many unknowns still surround the EU tariffs, including how the U.S.’ Section 232 investigation into the national security implications of pharmaceutical imports could influence the current rate, if at all. Further, in a potentially key carveout for Teva, certain generic drugs will be excluded from the tariffs, though it’s currently unclear which ones.Teva has “done very comprehensive work to understand how we can mitigate the impact [of tariffs] on our business,” the company’s CEO, Richard Francis, said on the call. He cautioned, however, that “there’s a lot of ambiguity about what really occurred with these tariffs,” referring to the 15% duties in the U.S.-EU accord.“I think the way we’ve always played this on tariffs is to be very conservative,” Francis added. “[W]e think about this comprehensively, and probably with a more glass-half-empty approach.”Francis noted that the company has several mitigation plans prepped that Teva can roll out once more details on the Trump administration’s pharmaceutical tariffs become clear.Teva has good reason to want to keep those tariffs from impacting its business as it continues a sales growth rebound and innovative medicines pivot under a multi-year turnaround strategy dubbed “Pivot to Growth.”While Teva is continuing to make good on many different aspects of its plan, the company’s performance in the second quarter was a bit more mixed than it has been in other recent earnings periods.All told, Teva’s revenue grew 1% at constant currencies to $4.2 billion after taking sales from the company’s generics joint venture with Takeda out of the mix. Late last year, Teva and Takeda decided to divest the Japan business to better focus on their own innovative medicine ambitions.When including the Japan JV sales, Teva’s total revenue for the period was flat year over year, according to a company earnings presentation (PDF).Nevertheless, Teva’s focus on its innovative portfolio continues to pay off, with the company now raising its full-year sales guidance for all three of its key marketed meds: Austedo, Uzedy and Ajovy.Teva’s chief drug, Austedo—approved in Huntington’s disease and tardive dyskinesia—grew sales 19% to $498 million for the quarter and is now expected to bring home sales between $2 billion and $2.05 billion for the year, compared to a previous range of $1.95 billion to $2.05 billion.Ajovy for migraine prevention, which delivered second-quarter sales growth of 31% to $155 million, is now pegged to reach sales between $630 million and $640 million, versus a prior projection of roughly $600 million.And Teva’s long-acting risperidone product for schizophrenia, Uzedy, is now in the running to secure $190 million to $200 million in 2025 sales after growing 120% in Q2 to $54 million.Uzedy has fared well in the risperidone and long-acting markets, but Teva now aims to “compete in the broader market of schizophrenia,” Francis said on the call. “So, we’ll be looking for patients to benefit from this on other molecules currently,” he explained.The CEO reiterated that Teva aims to launch the anticipated second half of its long-acting schizophrenia portfolio—long-acting olanzapine—in 2026. Together, the company estimates that the long-acting schizophrenia franchise can deliver combined peak sales of $1.5 billion to $2 billion.The consistent growth of Teva’s innovative drug trio helps affirm the company’s multiyear turnaround thesis, Francis said.When Teva first telegraphed its new growth strategy some two years back, “there was a question mark,” Francis said in an interview following the company’s earnings call. “Can Teva sell innovative drugs? And now we continue to show quarter on quarter we can.” He added that “there’s no secret sauce to this,” explaining that the company is simply hitting on commercialization fundamentals and doing them well. The company’s generics business, meanwhile, fell 2% for the period. Teva called the comparison “flat,” as Francis attributed it to both the timing of shipments of generic Revlimid and a tough comparison to Teva’s second quarter in 2024, when the company benefited from the launch of its Victoza GLP-1 copycat.The company’s biosimilars business, on the other hand, is booming.“We’ve seen some really good sales momentum in the U.S., and that’s been driven by our established brands, as well as our new launches with Selarsdi and generic Soliris that we launched in Q1 this year,” Francis said on Teva's earnings call. Selarsdi is Teva’s biosimilar to Johnson & Johnson’s Stelara.Teva is planning two more biosimilar launches before the year is out.  “I think the thing that I’m seeing people take away is the transition from Teva as pure play generics to a biopharma company seemed like it was fiction two years ago,” Francis said in the interview with Fierce.“How could it be done,” he continued. “What we’re seeing now, with our ability to handle a flat generics quarter, because of our innovative growth, shows we’re well on our way to doing that, and I think that’s really exciting.” Editor's note: This story was updated with additional comments from an interview with Teva's CEO at 1:38 pm ET on July 30.