Latest news with #fremanezumab
Yahoo
08-07-2025
- Business
- Yahoo
Teva's Ajovy Shows Sustained Long-Term Efficacy in Migraine Prevention Trial
Teva Pharmaceutical (NYSE:TEVA) is one of the most undervalued large cap stocks to buy according to analysts. On June 24, Teva Pharmaceutical announced the final analysis results from its PEARL Phase IV migraine prevention trial for Ajovy (fremanezumab), which is an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody. The study included individuals with both chronic and episodic migraine and confirmed the achievement of its primary and secondary endpoints. The final data demonstrated that over 66% of EM patients and 51.6% of CM patients who met the primary goal within the initial 6 months continued to experience significant benefits in migraine prevention for more than 24 months. A close-up shot of various types of medicines on a table, illustrating the specialty and generic products offered by the pharmaceutical company. Furthermore, the trial observed high injection adherence rates, nearing 90%, throughout the study duration, with over 75% of subjects completing the full 24-month study. The long-term tolerability and safety profile of fremanezumab remained consistent with previous interim analyses and randomized controlled studies. Teva Pharmaceutical (NYSE:TEVA) develops, manufactures, markets, and distributes generic and other medicines and biopharmaceutical products in the US, Europe, Israel, and internationally. While we acknowledge the potential of TEVA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
23-06-2025
- Health
- Yahoo
Final Data from Teva's PEARL Real-World Study Reinforce the Long-term Effectiveness of AJOVY® (fremanezumab) for the Prevention of Chronic and Episodic Migraine
Final analysis of PEARL real world migraine prevention study presented at 11th Congress of the European Academy of Neurology (EAN 2025) Congress in Helsinki1,2 Fremanezumab demonstrated sustained effectiveness and a favourable safety and tolerability profile over the two-year study period1,2 Injection adherence remained high throughout the study (~90%), while over 75% of patients completed the study duration1 TEL AVIV, Israel, June 23, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the final analysis of the pan-European PEARL Phase 4 migraine prevention study showed that AJOVY (fremanezumab), an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, delivered sustained effectiveness over a two-year period in reducing frequency, duration and severity of migraine attacks in patients with chronic and episodic migraine.1 The final data was presented at the Congress of the European Academy of Neurology (EAN 2025) congress in Helsinki confirming that primary and secondary endpoints had been met.1 Investigators concluded that the findings underscore the sustained effectiveness and the robust injection adherence rates to long-term fremanezumab treatment in migraine prevention.1 'Over the last two years, we have observed the benefit of fremanezumab for sustained migraine prevention and its positive impact on patient outcomes,' says Messoud Ashina, Professor and Director of the Human Migraine Research Unit, the Danish Headache Center and Department of Neurology. 'The PEARL study has provided valuable insight, not only into the pivotal role that fremanezumab can play in migraine prevention, but also in the importance of real-world studies in helping build our knowledge and shape clinical practice.' PEARL, a 24-month real-world observational study assessed the impact of fremanezumab for migraine prevention in 1,140 patients, predominantly female (87.25%) with 33.1% living with episodic migraine (EM), and 66.9% with chronic migraine (CM). The final study showed that over 66% of patients with EM and 51.6% with CM who had achieved the primary endpoint of a ≥50% reduction in Monthly Migraine Days (MMD) during the first 6 months of treatment benefitted from sustained migraine prevention for over 24 months. Injection adherence rates remained high throughout (~90%) the study, with over 75% (854/1129) of participants completing the study duration.1 The investigators also noted the favourable long-term safety and tolerability of fremanezumab that was consistent with its known safety profile from previous PEARL interim analyses and randomised controlled trials, supporting its continued clinical use for migraine prevention.2 'The final analysis of the PEARL real-world study reaffirms the long-term effectiveness and safety profile of fremanezumab in the preventive treatment of chronic and episodic migraine,' said Pinar Kokturk, M.D., Vice President and Head of Medical Affairs Europe at Teva. 'These data provide valuable real-world evidence supporting fremanezumab's sustained clinical benefit, particularly in a population burdened by high disease impact and a need for preventive therapy. With migraine being the second leading cause of disability worldwide,3 the recognition of CGRP-pathway therapies by health authorities is critical for improving patient outcomes.' Editors' Notes PEARL (Pan-European Real-World study), a two-year prospective, observational Phase IV study is investigating the effectiveness of AJOVY® (fremanezumab) in 1140 patients with chronic or episodic migraine. Fremanezumab is a humanised monoclonal antibody (mAb) that selectively targets the calcitonin gene-related peptide (CGRP) pathway. Of the 1140 participants enrolled, 1129 were included in the effectiveness analysis (EM, 33.1%; CM, 66.9%; 87.2% female). Eligible participants were adults with EM or CM receiving fremanezumab for migraine prevention, who maintained a daily headache diary prior to and throughout the study period. The primary endpoint was the proportion of participants with >=50% reduction in monthly migraine days (MMD) during the 6-month period after fremanezumab initiation. Secondary endpoints across Months 1–24 included mean change from baseline in MMD, and treatment adherence (participants who took their prescribed dose within ±5 days of the scheduled monthly/quarterly dosing regimen, per injection) and persistence. About AJOVY® (fremanezumab-vfrm) injection AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a health care professional or at home by a patient or caregiver. No starting dose is required to begin treatment. Information for Europe about AJOVY can be found here. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit Cautionary Note Regarding Forward-Looking Statements This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AJOVY (fremanezumab) for the prevention of chronic or episodic migraine; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned 'Risk Factors.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Teva Media Inquiries:TevaCommunicationsNorthAmerica@ Teva Investor Relations Inquires:TevaIR@ References 1. Ashina M. et al, Real-World Effectiveness of Fremanezumab in Migraine Prevention: Final Outcomes of the Pan-European PEARL Study (EPR-039), poster presented at the European Academy of Neurology (EAN) Congress; 21 – 24 June, 2025; Helsinki, Finland.2. Ashina M et al, Real-World Safety and Tolerability of Fremanezumab in Migraine Prevention: Final Outcomes of the PEARL Study (EPO-063), poster presented at the European Academy of Neurology (EAN) Congress; 21 – 24 June, 2025; Helsinki, Finland.3. Steiner, T.J., Stovner, L.J., Jensen, R. et al. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain 21, 137 (2020).Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
13-05-2025
- Health
- Medscape
Fremanezumab Shows Promise for Migraine Plus Depression
Fremanezumab was associated with a significantly greater reduction in monthly migraine days and symptoms of depression than placebo in patients with migraine and comorbid major depressive disorder (MDD), new research showed. METHODOLOGY: UNITE, a double-blind, placebo-controlled, parallel-group randomized clinical trial, was conducted at 55 centers across 12 countries between 2020 and 2022. It consisted of a 4-week screening period, a 12-week double-blind period, and a 12-week open-label extension. A total of 353 adult patients (mean age, 43 years; 88% women) with episodic migraine (48%) or chronic migraine (52%) and comorbid MDD for 12 months or more were randomly assigned to receive either 225 mg/mo fremanezumab (n = 175) or matching placebo (n = 178). Active depression symptoms were assessed using the Hamilton Depression Rating Scale-17 items (HAM-D 17) and nine-item Patient Health Questionnaire. Endpoints included mean changes from baseline in the average number of monthly migraine days at 12 weeks and in depressive symptom scores at 8 weeks. TAKEAWAY: At 12 weeks, 33% vs 13% of patients taking fremanezumab vs placebo achieved a ≥ 50% reduction in the number of monthly migraine days ( P < .001), with a mean reduction of 5.1 vs 2.9 days ( P < .001). < .001), with a mean reduction of 5.1 vs 2.9 days ( < .001). HAM-D 17 scores at 8 weeks were significantly reduced in the fremanezumab group vs the placebo group (mean reduction in scores, 6.0 vs 4.6; P = .02). = .02). In all, 40% of the fremanezumab group and 27% of the placebo group reported at least one adverse event of mostly mild or moderate severity at 12 weeks. Improvements in both migraine and depressive symptoms were maintained even throughout the open-label extension. IN PRACTICE: 'Recommendations have focused on treating patients with migraine and comorbidities with a single drug to address both, as this approach appears to simplify management, reduce costs, minimize potential AEs [adverse events], and eliminate potential drug interactions,' the investigators wrote. However, 'Fremanezumab may provide an effective and well-tolerated preventive treatment option for this patient population,' they added. SOURCE: This study was led by Richard B. Lipton, MD, Albert Einstein College of Medicine, New York City. It was published online on May 5 in JAMA Neurology . LIMITATIONS: This study excluded patients with uncontrolled psychiatric or bipolar disorders, limiting its generalizability. Potential drug interactions with fremanezumab and unrecorded dose adjustments may have influenced the outcomes. Depression was not tracked weekly, preventing the analysis of the timing between improvements in migraine and mood. Additionally, the predominantly White study population limited the generalizability to more diverse groups. DISCLOSURES: Funding information was not provided for the study. Several investigators reported having financial or employment ties with various pharmaceutical companies, including the manufacturer of fremanezumab. Full details are provided in the original article.
