In a significant development for hereditary angioedema (HAE) patients, Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted therapy designed to prevent HAE attacks in individuals aged 12 and older. The FDA has set a Prescription Drug User […]
Takeda has announced a significant advancement in the treatment of Hereditary Angioedema (HAE), with the European Commission’s approval of TAKHZYRO (lanadelumab) for routine prevention in patients aged 2 years and older. This approval marks the first long-term prophylactic HAE treatment available in the European Economic Area for patients under six years of age, broadening the […]
In a pivotal move bolstering its footprint in the global pharmaceutical landscape, Aurobindo Pharma Limited’s subsidiary, Eugia Pharma Specialities Limited, has achieved final authorization from the US Food & Drug Administration (FDA) to produce and commercialize their Icatibant Injection, 30 mg/3 mL. This development comes as a significant milestone as the injection stands as a […]
Ionis Pharmaceuticals, a US-based developer of RNA-targeted therapies, has launched the OASIS-HAE phase 3 clinical trial for donidalorsen (formerly IONIS-PKK-LRx) in patients having hereditary angioedema (HAE). Donidalorsen, which is an investigational antisense drug, is designed to lower the production of prekallikrein, which has a major role in triggering inflammatory mediators pertaining to acute attacks of […]