Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

Shots: The EC has approved Xoanacyl (ferric citrate complex) for chronic kidney disease; UK's MAA was filed via MHRA's IRP Approval was supported by 3 pivotal trials conducted by Akebia Therapeutics, which showed increased iron levels along with reduction in serum phosphorus in CKD pts Averoa licensed Xoanacyl from Akebia in Dec 2022, enhancing its…

ByRidhi RastogiJune 16, 2025

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Alnylam Pharmaceuticals’ Amvuttra Receives the EC’s Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Shots: The EC has approved Amvuttra (vutrisiran) to treat ATTR-CM adults as an additional indication, based on the global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts The study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved outcomes of mortality, CV events & functional capacity with 6min. walk…

ByDipanshu DixitJune 10, 2025

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Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Shots: The EC has granted conditional approval to Duvyzat (givinostat) for the treatment of ambulant DMD pts (≥6yrs.) on corticosteroids, regardless of underlying genetic mutation in all 30 EEA states Approval was based on the P-III (EPIDYS) study assessing Duvyzat (BID) vs PBO in ambulant DMD boys (n=179) on corticosteroid therapy Trial met its 1EP…

ByRidhi RastogiJune 9, 2025

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Sydnexis’ SYD-101 Receives the EC’s Approval to Reduce Pediatric Myopia Progression

Shots: The EC has approved SYD-101 to slow pediatric myopia progression; NDA is under the US FDA’s review (PDUFA: Oct 23, 2025) Approval was based on P-III (STAR) trial evaluating SYD-101 to reduce pediatric myopia progression & risk of associated co-morbidities in pts (3-14yrs. at trial initiation), which met its 3yr. 1EP, with third-year data…

ByRidhi RastogiJune 6, 2025

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The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy

Shots: The EC has approved label extension of Evrysdi (5mg oral tablet) for pts with spinal muscular atrophy (SMA) Approval was based on P-I study assessing Evrysdi 5mg tablet vs oral solution, showing bioequivalence with comparable efficacy & safety; data was presented at SMA Europe 2024 Evrysdi, an SMN2 splicing modifier, treats SMA caused by…

ByRidhi RastogiJune 5, 2025

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Takeda’s Adcetris Regimen Receives the EC’s Approval to Treat Newly Diagnosed Hodgkin Lymphoma

Shots: The EC has approved Adcetris (brentuximab vedotin) + ECADD (etoposide, cyclophosphamide, doxorubicin, dacarbazine & dexamethasone) to treat adults with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma following CHMP’s positive opinion in Apr 2025 Approval was based on P-III (HD21) trial assessing Adcetris + ECADD vs escalated doses of BEACOPP in above pts,…

ByRidhi RastogiJune 4, 2025

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Fresenius kabi Secures the CHMP’s Positive Opinion for Bomyntra & Conexxence (Biosimilar, Prolia and Xgeva)

Shots: The CHMP has recommended a positive opinion for the marketing authorization of Bomyntra and Conexxence, biosimilars of Bayer’s Xgeva and Prolia (denosumab). EC approval is anticipated in Q3’25 The MAA submissions were based on comprehensive analytical similarity assessments and two comparative clinical studies: one on PK, PD, and immunogenicity in healthy volunteers, and another assessing efficacy, PD,…

ByDipanshu DixitMay 27, 2025

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Autolus Therapeutics’ Obecabtagene Autoleucel Receives the CHMP’s Positive Opinion for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots: The CHMP has recommended Obecabtagene Autoleucel (obe-cel; autologous CD19 CAR T cell therapy) for treating pts (≥26yrs.) with r/r B-ALL; EC’s decision on conditional MAA is expected within 2mos. Opinion was based on the P-Ib/II (FELIX) study assessing obe-cel in over 100 adults with r/r B-cell precursor ALL across 30 sites in the US, UK &…

ByRidhi RastogiMay 27, 2025

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BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

Shots: The EC has approved Opdivo + CT as neoadj. therapy followed by surgery & adj. Opdivo alone to treat adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1% in all 30 EEA states Approval was based on P-III (CheckMate-77T) study assessing neoadj. Opdivo + CT vs neoadj. PBO & CT…

ByRidhi RastogiMay 19, 2025

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AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)

Shots: The EC has approved Calquence + bendamustine & rituximab for the treatment of ASCT-ineligible pts with previously untreated MCL; regulatory review is ongoing in Japan & other regions Approval was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed improved PFS of 27%,…

ByRidhi RastogiMay 8, 2025

Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

Alnylam Pharmaceuticals’ Amvuttra Receives the EC’s Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Sydnexis’ SYD-101 Receives the EC’s Approval to Reduce Pediatric Myopia Progression

The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy

Takeda’s Adcetris Regimen Receives the EC’s Approval to Treat Newly Diagnosed Hodgkin Lymphoma

Fresenius kabi Secures the CHMP’s Positive Opinion for Bomyntra & Conexxence (Biosimilar, Prolia and Xgeva)

Autolus Therapeutics’ Obecabtagene Autoleucel Receives the CHMP’s Positive Opinion for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)

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