Latest news with #Ajovy
Canada News.Net
4 days ago
- Health
- Canada News.Net
Ajovy becomes the first FDA-approved migraine prevention for kids
SILVER SPRING, Maryland: The U.S. Food and Drug Administration has approved Teva Pharmaceuticals' Ajovy for use in children, marking the first time a migraine prevention drug has been cleared for pediatric patients. Ajovy, an injectable treatment already approved for adults, can now be used in children aged six and older who weigh at least 45 kilograms (about 99 pounds), the FDA said this week. The medication is administered once a month. This expanded approval offers a new option for families of children suffering from episodic migraines—severe, recurring headaches that occur frequently enough to disrupt daily life but not on a daily basis. In children, these headaches are often accompanied by nausea, fatigue, and sensitivity to light and sound. Ajovy belongs to a class of medications known as CGRP (calcitonin gene-related peptide) inhibitors, which work by blocking a protein associated with triggering migraines. The drug was first approved in 2018 for adult use and now joins its rivals, Amgen's Aimovig and Eli Lilly's Emgality, in the pediatric space. However, Ajovy is the first among them to secure FDA approval for migraine prevention in children. In clinical trials, the most common side effects in children were pain and redness at the injection site. The FDA noted that the overall safety profile in pediatric patients was similar to that seen in adult studies. More serious but less common side effects include rash, itchiness, and hypersensitivity to the drug. Migraine is one of the most common neurological conditions in children and adolescents, and options for prevention have long been limited. Pediatric neurologists have often relied on off-label prescriptions of adult medications or lifestyle adjustments to manage the condition. The FDA's approval of Ajovy for children could help shift that treatment landscape. Ajovy's pediatric approval also strengthens Teva's position in the competitive CGRP inhibitor market. While Amgen's Aimovig and Lilly's Emgality have gained traction among adult patients.
Yahoo
5 days ago
- Health
- Yahoo
Teva's Ajovy becomes first migraine prevention drug approved for children
The US Food and Drug Administration (FDA) has approved a label expansion to Teva's Ajovy in certain children and adolescents, making it the first migraine prevention drug of its kind in the age group. Single-dose injectable Ajovy (fremanezumab-vfrm) is now approved for the preventive treatment of episodic migraine in children and adolescent patients aged between six and 17 years who weigh 45kg or more. Ajovy is part of a class of drugs called calcitonin gene-related peptide (CGRP) inhibitors, which block a protein involved in triggering migraines. The FDA approved Ajovy for adults in 2018. Israel-based Teva narrowly missed having the first CGRP-targeting drug approved for migraines at the time, following Novartis and Amgen's Aimovig (erenumab) approval earlier in the year. However, the therapy is not approved for children or adolescents, meaning its patient reach is now not as wide as Ajovy. One in ten children and adolescents in the US suffers from migraines, one of the most common neurological conditions. Paediatric migraine is often underrecognised and undertreated, disrupting lifestyle such as school attendance and social interactions. Episodic migraine refers to recurring severe headaches in children that do not occur daily but are frequent enough to interfere with daily activities. Ajovy is administered once a month and available for in-office or at-home use, offering an accessible treatment option for patients and their caregivers, such as parents. A higher-dose version, given every three months as three injections, is also available for adults. Teva's Phase III SPACE trial (NCT03539393) with the drug demonstrated statistically significant superior efficacy compared to placebo over three months in the paediatric population. The safety profile was consistent with that in the adult population – the most common side effects being itchiness, rash and drug hypersensitivity. Teva's global marketing business head Chris Fox said: 'Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood. '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.' The label expansion in children and adolescents gives Teva an edge over Novartis/Amgen, as well as Eli Lilly, whose Emgality (galcanezumab) – also a CGRP inhibitor – is also approved and on the market. Last year, Teva's migraine treatment Ajovy generated $507m in global sales, an 18% increase compared to the previous year. Analysis by GlobalData forecasts sales of $885m by 2031. Neither Amgen nor Lilly disclosed specific sales for their two products in 2024. GlobalData is the parent company of Pharmaceutical Technology. "Teva's Ajovy becomes first migraine prevention drug approved for children" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Reuters
6 days ago
- Health
- Reuters
US FDA approves Teva's Ajovy for migraine prevention in children
Aug 5 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Ajovy, an injection made by Israeli drugmaker Teva Pharma ( opens new tab, to help prevent migraines in children aged six and older who weigh 45 kilograms or more. This is the first time a drug has been approved for preventing migraines in children. The injection is given once a month. The most common side effects are pain and redness where the shot is given. Serious side effects include itchiness, rash and drug hypersensitivity, but the overall safety was similar to what was seen in adult migraine studies, the FDA said. Episodic migraine refers to recurring severe headaches in children that do not occur daily but are frequent enough to interfere with daily activities. These headaches are often accompanied by symptoms such as nausea, fatigue and sensitivity to light and sound. Ajovy is part of a class of drugs called CGRP inhibitors, which block a protein involved in triggering migraines. The treatment was first approved for adults in 2018 and competes with similar drugs such as Amgen's (AMGN.O), opens new tab Aimovig and Eli Lilly's (LLY.N), opens new tab Emgality.
Yahoo
01-08-2025
- Business
- Yahoo
TEVA Q2 Earnings Beat, Revenues Miss on Lower Generics Sales
Teva Pharmaceutical Industries TEVA reported second-quarter 2025 adjusted earnings of 66 cents per share, which beat the Zacks Consensus Estimate of 63 cents. Adjusted earnings rose 8% year over year, driven by higher operating profits. Revenues for the second quarter were $4.18 billion, which missed the Zacks Consensus Estimate of $4.28 billion. Total revenues were flat year over year on a reported basis and down 1% on a constant currency basis. Revenue growth suffered as the gains from the increasing sales of its branded drugs, Austedo, Ajovy, and Uzedy, were offset by lower generic drug sales in Teva's U.S. and international markets, mainly resulting from its exit from Japan. Branded Products Drive TEVA's US Unit's Sales Sales in the United States segment were $2.15 billion, up 2% year over year, driven by higher revenues from Teva's branded drugs, Ajovy, Austedo and Uzedy, partially offset by a decline in generic revenues. The segment's sales missed the Zacks Consensus Estimate of $2.19 billion but beat our model estimate of $2.11 billion. Generic/biosimilar product revenues declined 6% from the year-ago period to $961 million in the United States due to lower revenues from the generic versions of Revlimid and Victoza. Generic revenues missed the Zacks Consensus Estimate of $1.05 billion as well as our model estimate of $1.02 billion. Teva's ne generic drugs includes Simlandi, a generic version of AbbVie's ABBV Humira, which was approved in February 2024 and launched in May. Teva also has other high-value complex generics like Selarsdi. Notably, Selarsdi is a biosimilar version of J&J's JNJ Stelara, which was approved in April 2024 and launched in February 2025, per settlement terms with J&J. Simlandi and Selarsdi are the first two biosimilars to launch in the United States under the Teva and Alvotech strategic partnership, which includes nine products. Teva and partner Samsung Bioepis' Epysqli, a biosimilar version of AstraZeneca's Soliris, was launched in the United States in early April. Teva entered into a strategic partnership with Samsung Bioepis in January 2025 for the commercialization of Epysqli in the United States. So far this year, shares of TEVA have plunged 23.6% compared with the industry's decline of 9.8%. Image Source: Zacks Investment Research Huntington's disease drug, Austedo, recorded sales of $495 million in the United States, up 22% year over year. Sales were mainly driven by volume growth as prescription trends continued to grow. Austedo sales missed the Zacks Consensus Estimate of $501.7 million while marginally beating our model estimate of $494.8 million. Ajovy recorded sales of $63 million in the quarter, up 53% year over year, driven by volume growth. Ajovy sales surpassed the Zacks Consensus Estimate of $50.8 million as well as our model estimate of $42.6 million. Uzedy (risperidone), a long-acting subcutaneous atypical antipsychotic injection for the treatment of schizophrenia, generated sales of $54 million in the second quarter, up 120% year over year, mainly driven by volume growth. Copaxone recorded sales of $62 million in the United States, down 23% year over year, mainly due to market share erosion and competition. Copaxone sales beat the Zacks Consensus Estimate of $48.8 million as well as our model estimate of $45.8 million. Performance of TEVA's Europe and International Market Units The Europe segment recorded revenues of $1.3 billion, up 7% year over year on a reported basis. Sales were up 3% on a constant currency basis, mainly driven by the sale of certain product rights, higher revenues from Ajovy and generic products. Europe revenues beat the Zacks Consensus Estimate as well as our model estimate of $1.25 billion. In the International Markets segment, sales declined 17% year over year to $495 million. In constant currency terms, sales decreased 16% year over year, mainly due to the divestment of Teva's business venture in Japan. International Markets revenues missed the Zacks Consensus Estimate of $602.4 million as well as our model estimate of $651.3 million. The Other segment (comprising the sales of active pharmaceutical ingredients to third parties and certain contract manufacturing services) recorded revenues of $232 million, down 7% year over year on a reported basis and down 9% year over year on a constant currency basis. TEVA's Margin Discussion Adjusted gross margin was 54.6% for the quarter, up 170 basis points (bps) year over year. The rise is mainly driven by higher Austedo revenues, the sale of certain product rights in Europe and the divestment of the business venture in Japan, partially offset by lower Copaxone revenues. Adjusted research & development expenses decreased 9% year over year to $244 million. Selling and marketing expenditure was comparatively flat year over year at $654 million. General and administrative expenses increased 8% from the prior-year level to $305 million. Adjusted operating income rose 7% year over year in the second quarter to $1.13 billion. Adjusted operating margin increased 180 bps to 27.1% in the quarter, mainly due to higher gross profit margin as well as lower operating expenses as a percentage of revenues. Teva expects an adjusted operating margin of 30% by 2027 to be achieved by cost savings and the continued growth of its branded drugs. Teva Pharmaceutical Industries Ltd. Price, Consensus and EPS Surprise Teva Pharmaceutical Industries Ltd. price-consensus-eps-surprise-chart | Teva Pharmaceutical Industries Ltd. Quote TEVA Updates Guidance for 2025 Teva continues to expect its total revenues in 2025 to be in the range of $16.8-$17.2 billion. Teva raised the lower end of its expectation for Austedo from $1.95-$2.05 billion to $2-$2.05 billion. The company also raised its full-year guidance for Ajovy sales from $600 million to the range of $630-$640 million. Uzedy guidance has been raised from $160 million to the range of $190-$200 million in 2025. Copaxone guidance was maintained at $370 million. Teva expects adjusted EPS to be in the range of $2.5-$2.65 per share in 2025 compared with the prior expectation of $2.45-$2.65. The company continues to expect its adjusted operating income to be in the range of $4.3-$4.6 billion in 2025. Adjusted EBITDA was maintained in the range of $4.7-$5 billion. TEVA's Zacks Rank Teva currently has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Johnson & Johnson (JNJ) : Free Stock Analysis Report Teva Pharmaceutical Industries Ltd. (TEVA) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Reuters
30-07-2025
- Business
- Reuters
Teva Pharm's second-quarter profit boosted by branded drugs, US tariff questions remain
JERUSALEM, July 30 (Reuters) - Teva Pharmaceutical Industries ( opens new tab reported a better than expected increase in second-quarter profit on Wednesday, helped by a 26% rise in sales of its branded drugs and said it was well positioned to mitigate potential U.S. tariffs. Richard Francis, CEO of Teva, the world's largest generic drugmaker, said there was "big ambiguity" and "so many unanswered questions" in the pharmaceuticals sector regarding potential U.S. import levies. He added, however, that the Israel-based company, had been leveraging its U.S.-based manufacturing facilities and its minimal reliance upon China and India to soften the blow from any eventual tariffs. "Those aspects just set us up in the face of this change, probably a lot better than our competitors," Francis told Reuters. "I feel we have the ability to put ourselves in a good position here, with the caveat - I need to know the details." U.S. President Donald Trump initially threatened Israel with a 17% import tariff on its exports to the United States. But what will happen after his August 1 deadline expires remains unclear. Global drugmakers also face the possibility of a sector-specific U.S. tariff on pharmaceuticals despite some drug shortages in the United States. Teva said it earned 66 cents per diluted share, excluding one-time items, in the April-June quarter, up from 61 cents a share a year earlier. Revenue was flat in dollar terms at $4.18 billion. Analysts had forecast earnings of 62 cents per share ex-items for the Israel-based company on revenue of $4.28 billion, LSEG I/B/E/S data showed. Teva largely reaffirmed its 2025 estimates but revised its adjusted EPS forecast to $2.50-$2.65 from $2.45-$2.65. It still projects revenue of $16.8 billion to $17.2 billion this year and said it was on track for 30% operating profit margin by 2027. After a strong 2024, generic drugs were largely flat globally in the quarter, falling in the United States but offset by gains in Europe. Among its branded drugs, sales of its Huntington's Disease treatment Austedo grew 19% to $498 million, while migraine medicine Ajovy rose 31% to $155 million and Uzedy, a drug to treat schizophrenia, jumped 120% to $54 million. As a result, Teva raised its estimate for 2025 sales of Austedo slightly to $2 billion to $2.05 billion. It sees sales of Ajovy at $630 million to $640 million and Uzedy at $190 million to $200 million. It added it would double biosimilar revenues from 2024 to 2027 and said it remained in negotiations to sell its active pharmaceutical ingredients unit. Teva, Francis noted, has a large pipeline of drugs that will be launched in the coming decade - starting with schizophrenia drug Olanzapine in the fourth quarter - that combined will likely peak at more than $10 billion in sales. Its New York-listed shares were up 2.9% at $17.15 in mid-morning trade.
