1. U.S. FDA Approval granted to J&J’s new VARIPULSE™ Platform
Johnson & Johnson MedTech announced the U.S. FDA approved the VARIPULSE™ Platform for the treatment of drug-refractory paroxysmal Atrial Fibrillation (AFib). Atrial fibrillation (Afib) is an irregular heart rhythm that begins in your heart's upper chambers. Heart tissue changes or the associated electrical signalling defects are possible causes of the disease. The newly designed platform benefits patients who are not responding well to medications. The technology integrates pulsed field ablation (PFA) therapy with advanced mapping capabilities using the CARTO™ 3D cardiac mapping system. The approval is supported by positive results from the admIRE non-randomized trial. All the patients achieved acute procedural success, including 98% with first-pass isolation recorded per vein and minimal adverse events were observed.
Source: https://www.jnj.com/media-center/press-releases/johnson-johnson-medtech-receives-fda-approval-for-the-varipulse-pulsed-field-ablation-platform-for-the-treatment-of-atrial-fibrillation
2. A new indication of daratumumab has been filed to the regulatory body for approval seeking
Johnson & Johnson submitted new regulatory applications to the U.S. FDA and European Medicines Agency for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX® subcutaneous (SC) formulation in the EU. The applications are supported by the ongoing Phase 3 AQUILA study. The trial is a randomized, multicenter Phase 3 study investigating DARZALEX FASPRO® versus active monitoring in patients (n=390) with high-risk smouldering multiple myeloma. Smouldering multiple myeloma is a precursor to active multiple myeloma where most patients are asymptomatic. Daratumumab is an antibody targeting CD38, inducing malignant B cell apoptosis via antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, inhibition of mitochondrial transfer or antibody-dependent cellular phagocytosis.
Source: https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-applications-in-the-u-s-and-eu-seeking-approval-of-darzalex-faspro-darzalex-as-subcutaneous-monotherapy-for-high-risk-smoldering-multiple-myeloma
3. Approval of Dupixent in children from one to 11 to treat eosinophilic esophagitis
Sanofi and Regeneron announced that the European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged one to 11 years (at least 15kg). The new action expands the previous approval in adults and adolescents and Dupixent now is the first and only medicine for younger patients. The approval was supported by the data from the phase 3 EoE KIDS study. In Part A, 68% of patients receiving high Dupixent achieved histological disease remission, but there were only 3% in the placebo group. Moreover, there was also an 86% reduction in peak esophageal intraepithelial eosinophil count from baseline compared to a 21% increase in placebo. Dupixent works by inhibiting IL-4 and IL-13 signalling pathways, thereby reducing the disease’s inflammatory conditions.
Source: https://www.sanofi.com/en/media-room/press-releases/2024/2024-11-06-06-00-00-2975399
4. Positive results obtained from Tezspire Phase III study for the treatment of chronic rhinosinusitis with nasal polyps
AstraZeneca and Amgen announced results from Phase III WAYPOINT trial investigating the effects of Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps. The drug showed a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo. The disease is a complex inflammatory disorder where patients suffer from repeated nasal infections. Currently, the drug is approved for severe asthma, the positive results obtained might potentially expand the drug indication.
5. AB-1003 received received rare pediatric disease designation and orphan-drug designation from the U.S. FDA
Asklepios BioPharmaceutical, a gene therapy company under Bayer announced that their product AB-1003 has received rare pediatric disease designation and orphan-drug designation from the U.S. FDA for the treatment of limb-girdle muscular dystrophy type 2I/R9. The disease is a rare genetic disorder caused by mutations in the FKRP gene. The product is a novel investigational FKRP gene replacement therapy. Now the clinical trial is still under Phase 1/2 Phase, because of the designation, the product might be granted the priority review after endpoints are achieved.
Source: https://www.bayer.com/media/en-us/askbio-receives-fda-rare-pediatric-disease-and-orphan-drug-designations-for-ab-1003-for-the-treatment-of-limb-girdle-muscular-dystrophy-type-2ir9/
https://www.askbio.com/askbio-announces-first-patient-dosed-in-phase-1-phase-2-lgmd2i-r9/
6. Esprit™ BTK Everolimus Eluting Resorbable Scaffold System presented long-term efficacy data
Abbott announced results from the LIFE-BTK clinical trial. The second-year data showed the long-term effectiveness of the FDA-approved Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK) in people with the most severe form of peripheral artery disease below the knee. Results showed that the new system benefits patients more compared to the balloon angioplasty which is a conventional treatment. Peripheral artery disease refers to the narrowed arteries that reduce blood flow to the lower limbs. The system uses a bioresorbable scaffold to reverse vessel recoil. From the trial, 90.3% of patients in the Esprit BTK arm did not require a reintervention at 24 months. As for the primary clinical event, 61.5% of patients treated with Esprit BTK are free from chronic limb-threatening ischemia (a severe form of PAD), compared to 32.8% in the balloon angioplasty arm. Moreover, the Esprit BTK arm also presented a 35.2% improvement in reducing vessel re-narrowing compared to the balloon angioplasty group.
Source: https://abbott.mediaroom.com/press-releases?item=124676
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