Latest news with #Janssen-Cilag
7NEWS
01-05-2025
- Health
- 7NEWS
Children bearing the brunt of ADHD medicine shortage
Australian children and teenagers face the biggest impacts of an international shortage of critical ADHD medications. The nation's health regulator says certain drugs used to treat attention deficit hyperactivity disorder are in short supply and it could last until the end of 2025. This stock shortfall could negatively affect young children and adolescents who cannot access their specially prescribed doses, pediatrician Sarahn Lovett said. 'When you have a child who is doing well on a slow-release medication for ADHD ... it can be really challenging for them to go backwards because ... they are not developmentally able to cope with those ups and downs,' the Australasian ADHD Professionals Association vice president said. Switching doses for other available options could force school children who usually take one tablet before school to take a second during school hours. 'It can be a point of bullying, it can be a point of social isolation and also can be a disclosure of their diagnosis,' Lovett said. It can also shorten their days in terms of extracurricular activities or homework because the effects wear off quicker than usual. The Therapeutic Goods Administration has urged patients and their families to consider other brands, including overseas-registered products, during the unavoidable shortages. 'Please note that certain medicines a pharmacist can substitute may cost you more and in some cases you may require a new prescription,' it said. Several brands, including Janssen-Cilag and Teva Pharma's Concerta and Teva-XR products and Novartis and AFT Pharmaceuticals' Ritalin LA and Rubifen LA products were impacted, the TGA said. They affect different doses across the brands with some low in stock since September. The shortages have been blamed on manufacturing issues and increased demand caused by the unavailability of other methylphenidate products. Lovett said the medicines helped young people maintain relationships, make better choices and be less impulsive and were prescribed on doses that worked best with their personal circumstances. 'If 36mg becomes unavailable and the only other option is to go up to a 54mg dose, you sit much higher in the therapeutic window and you're much more likely to experience side effects,' the pediatrician said. Risks include young people losing their appetite during the day, resulting in weight loss, and impacting the individual's sleep onset. The health regulator has urged patients and caregivers to speak to their pharmacist about supply and their prescribers early to develop a treatment plan. To reduce the impact of shortages, it has approved a supply of overseas-registered Concerta tablets. The Australasian ADHD Professionals Association said Australia was experiencing a 'perfect storm' as it faced a shortfall in medication. The association said the active ingredient used in the drugs was produced in several countries, including China, India and the United States. But in the US, where the pharmaceutical companies make the products, the Drug Enforcement Administration imposes strict annual production quotas to prevent abuse. ADHD is a developmental disorder that begins in early childhood and over one million Australians are living with the condition, amounting to one in every 20 people.
Perth Now
01-05-2025
- Health
- Perth Now
'Perfect storm' as ADHD medications in short supply
A shortage of medications used to treat ADHD could leave more than one million Australians paying more for substitutes. The nation's health regulator says certain drugs used to treat attention deficit hyperactivity disorder are in short supply, and the shortage could last until the end of 2025. "We understand it can be frustrating when you are unable to get your preferred brand of a medicine, but using other brands, including overseas-registered products, may at times be unavoidable during these shortages," the Therapeutic Goods Administration said. "Please note that certain medicines a pharmacist can substitute may cost you more, and in some cases you may require a new prescription." Several brands, including Janssen-Cilag and Teva Pharma's Concerta and Teva-XR products and Novartis and AFT Pharmaceuticals' Ritalin LA and Rubifen LA products were impacted, the TGA said. They affect different doses across the brands with some being low in stock since September. The shortages of Concerta and Ritalin LA products are put down to manufacturing issues, while the shortage of Teva-XR and Rubifen LA products is due to increased demand caused by the unavailability of other methylphenidate products. The health regulator has urged patients and caregivers to speak to their pharmacist about supply and their prescribers early to develop a treatment plan. To reduce the impact of shortages, it has approved a supply of overseas-registered Concerta tablets. The Australasian ADHD Professionals Association said Australia was experiencing a "perfect storm" as it faces a shortfall in medication. "Australia is facing an escalating shortage of ADHD medications, and while emergency alternatives like a Swiss-registered Concerta are technically available ... the lack of PBS listing and long import delays make them inaccessible for most families," it said. The association said the active ingredient used in the drugs was produced in several countries, including China, India and the United States. In the US, where the pharmaceutical companies make the products, the Drug Enforcement Administration imposes strict annual production quotas to prevent abuse. "Even if demand increases legitimately or shortages loom, more (of the active ingredient) cannot be produced without a green light from the (regulator)," the association said. ADHD is a developmental disorder that begins in early childhood and affects people's ability to control thoughts, words, actions and emotions. More than one million Australians live with the condition, amounting to one in every 20 people.
Yahoo
13-04-2025
- Business
- Yahoo
EC approves extension of indication for Janssen-Cilag's Darzalex
The European Commission (EC) has approved the extension of indication for Janssen-Cilag International's Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults. Janssen-Cilag is a Johnson & Johnson (J&J) company. The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd). The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT). The latest approval follows October 2024's indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results. The trial focused on assessing the therapy's SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance. The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment. Daratumumab-VRd's overall safety profile was consistent with the known profiles of daratumumab SC and VRd. Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: 'Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility. 'This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.' J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred. In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM. In 2012, J&J's Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab. "EC approves extension of indication for Janssen-Cilag's Darzalex" 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.
Yahoo
13-04-2025
- Business
- Yahoo
EC approves extension of indication for Janssen-Cilag's Darzalex
The European Commission (EC) has approved the extension of indication for Janssen-Cilag International's Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults. Janssen-Cilag is a Johnson & Johnson (J&J) company. The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd). The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT). The latest approval follows October 2024's indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results. The trial focused on assessing the therapy's SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance. The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment. Daratumumab-VRd's overall safety profile was consistent with the known profiles of daratumumab SC and VRd. Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: 'Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility. 'This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.' J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred. In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM. In 2012, J&J's Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab. "EC approves extension of indication for Janssen-Cilag's Darzalex" 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
