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NEWS

BeOne Medicines’ BGB-16673 Receives the EMA’s PRIME Designation to Treat Waldenstrom’s Macroglobulinemia

Shots: The EMA has granted PRIority MEdicines (PRIME) designation to BGB-16673 for the treatment of pts with Waldenstrom’s macroglobulinemia (WM), who previously were treated with a BTK inhibitor Designation was based on data showing BGB-16673’s novel ability to degrade both wild-type & mutant BTK forms, incl. resistance-linked variants, which demonstrated anti-tumor activity in B-cell malignancies…
August 1, 2025

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IntraBio’s Aqneursa Receives the CHMP’s Positive Opinion for Treating Niemann-Pick Disease Type C (NPC)

Shots: The CHMP has recommended Aqneursa (levacetylleucine) for treating adults & pediatric pts with NPC; additional global submissions are planned for 2025 & beyond Approval was backed by P-III (IB1001-301) study assessing Aqneursa vs PBO in pts (≥4yrs.; n=60) with NPC, which showed improved neurological symptoms & function across all 1 & 2EPs within 12wks.,…
July 30, 2025

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Ionis
NEWS

Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

Shots: The CHMP has recommended Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome; EC’s decision is expected in Q4’25 Opinion was based on P-III (Balance) trial assessing (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute…
July 29, 2025

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NEWS

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Shots: The CHMP has recommended sebetralstat to treat acute attacks of hereditary angioedema (HAE) pts (≥12yrs.); EC’s decision expected by early Oct 2025. Application is under review in Japan & other regions Approval was based on P-III (KONFIDENT) study assessing sebetralstat (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries KONFIDENT data…
July 28, 2025

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NEWS

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

Shots:  The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states  The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…
July 24, 2025

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CuraTeQ
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The EC Approves CuraTeQ Biologics’ Dazublys (Biosimilars, Herceptin)   

Shots:  CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EC’s approval of Dazublys, its trastuzumab biosimilar following the CHMP’s recommendation in Apr 2025  The approval was based on its demonstrated similarity to Herceptin in PK, PD, efficacy, safety, and immunogenicity  Dazublys is approved for HER2-positive breast and gastric cancers, and expanding access to treatment across…
July 4, 2025

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