Latest news with #Aimovig
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
4 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
Yahoo
25-02-2025
- Health
- Yahoo
Pharmacy fined $1,000 for medication-dispensing error
The Hy-Vee Pharmacy at 410 N. Ankeny Blvd. in Ankeny, Iowa. (Photo via Google Earth) An Ankeny pharmacy has been fined $1,000 for dispensing the wrong medication to a customer and then failing to report the incident within the required timeframe. The Hy-Vee Pharmacy at 410 N. Ankeny Blvd. in Ankeny was charged by the Iowa Board of Pharmacy with incorrectly dispensing a prescribed medication to a patient and with failing to properly record all medication errors in its quality-control reports. The board alleges that on July 24, 2024, a patient went to Hy-Vee to pick up her prescription for Aimovig, a drug commonly used to treat migraine headaches. A pharmacy technician pulled the patient's will-call bag with the printed receipt but retrieved the wrong medication from the refrigerator. The pharmacy technician incorrectly provided the patient with Ajovy, another drug often used to treat headaches, that was prescribed for another patient, according to the board. The pharmacy did not discover the dispensing error for five days, when the second patient arrived to collect her prescribed allotment of Ajovy. It was then discovered that the Ajovy was missing, while the Aimovig — which had theoretically been given to the first patient — was still sitting on the shelf. Upon realizing what had transpired, the pharmacist in charge immediately called the first patient to determine whether, as suspected, she had mistakenly been given the Ajovy. The patient reported that she had, adding that she had disposed of the Ajovy, believing it to be an old prescription she had been given in error. Upon investigation, the board determined that the pharmacy did not report the medication error in its Continuous Quality Improvement report within the required timeframe of 24 hours. The board and the pharmacy recently agreed to a settlement that requires the Ankeny store to pay a $1,000 civil penalty and to provide all of its pharmacists and pharmacy technicians with a board-approved continuing education course on patient safety and the prevention of medication errors.
