Insights+: EMA Marketing Authorization of New Drugs in July 2024
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The EMA granted Positive Opinion to 2 Biologics and 5 New Chemical Entities in July 2024, leading to treatments for patients and advances in the healthcare industry
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The major highlighted drugs were Johnson & Johnson’s Yuvanci to treat Pulmonary Arterial Hypertension (PAH) and Astellas’ Vyloy + CT for Gastric & Gastroesophageal Junction Cancer
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PharmaShots has compiled a list of 7 drugs that have been granted positive opinion by the EMA’s CHMP
Product Name: Yuvanci
Active ingredient: Combination of Macitentan and Tadalafil
Company: Johnson & Johnson
Date: July 25, 2024
Disease: Pulmonary Arterial Hypertension
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The CHMP has granted positive opinion to Yuvanci [macitentan (10mg) + tadalafil (40mg)] as a substitution therapy of PAH adults, based on P-III (A DUE) study
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The P-III (A DUE) trial assessed Yuvanci STCT vs macitentan (10mg) & tadalafil (40mg) alone in PAH patients (n=187). Subjects with PVR ≥240 dyn×s/cm5 randomly received M/T STCT (n=108), macitentan alone (n=35) or tadalafil alone (n=44), QD
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Trial reached its 1EP, showing reduced PVR (as a ratio of wk.16 to baseline) of 29% (effect of 0.71) vs macitentan & 28% (effect of 0.72) vs tadalafil, with similar efficacy observed in subgroups of age, sex, race & baseline WHO FC as well as among treatment-naïve or experienced patients (with ERA or PDE5i)
Product Name: Anzupgo
Active ingredient: Delgocitinib
Company: LEO Pharma
Date: July 25, 2024
Disease: Chronic Hand Eczema
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The CHMP has granted positive opinion to Anzupgo cream (topical pan-JAK inhibitor) for treating moderate to severe chronic hand eczema (CHE), inadequately managed by topical corticosteroids
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Opinion was based on P-III (DELTA 1 & DELTA 2) trials assessing the safety & efficacy of Anzupgo (BID) vs vehicle for moderate to severe CHE. Those who concluded treatment for 16wks. were rolled over to 36wk. DELTA 3 extension study to assess long-term safety
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The DELTA 1 & 2 reached their 1EPs & 2EPs, with DELTA 3 trial showing the long-term safety that aligned with prior outcomes. The approval, if granted, would applicable across the whole EU plus Iceland, Norway & Liechtenstein; regulatory filings with other bodies are ongoing
Product Name: Iqirvo
Active ingredient: Elafibranor
Company: Ipsen
Date: July 25, 2024
Disease: Primary Biliary Cholangitis
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The CHMP’s positive opinion of Iqirvo (PPAR agonist) + ursodeoxycholic acid (UDCA) for PBC adults having inadequate UDCA response or Iqirvo alone for UDCA intolerant patients was based on P-III (ELATIVE) study. EC’s decision is anticipated in Q3’24. The company has submitted Iqirvo for PBC to the MHRA
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The P-III (ELATIVE) study assessed Iqirvo (80mg, QD) vs PBO to treat PBC patients (n=161) having inadequate response or intolerance to UDCA
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Study reached the composite 1EP of BCR, showing 47% treatment benefit in 51% vs 4% of them at wk.52 with an ALP reduction of 41% in 15% vs 0% of them at wk.4 that was sustained till wk.52
Product Name: Kayfanda
Active ingredient: Odevixibat
Company: Ipsen
Date: July 25, 2024
Disease: Cholestatic Pruritus in Alagille Syndrome
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The CHMP’s positive opinion of Kayfanda to treat cholestatic pruritus in ALGS individuals (≥6mos.) was based on P-III (ASSERT) study. EC’s decision is anticipated in Q3’24
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The P-III (ASSERT) study assessed the safety & efficacy of Kayfanda (120µg/kg/day) vs PBO for 24wks.to relieve itch in ALGS patients (n=52; 0-17yrs.) across North America, EU, the Middle East & the Asia Pacific regions
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Study reached its 1EP, showing improved pruritus after 6mos. (90% were itch responders) & 2EP, showing reduction in serum bile acid concentration after 20-24wks. and improved sleep parameters at wks.1-4 that sustained till wk.24
Product Name: Vevizye
Active ingredient: Ciclosporin
Company: Novaliq
Date: July 25, 2024
Disease: Dry Eye Disease
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The CHMP has granted a positive opinion to Vevizye in moderate to severe dry eye disease adults treated with tear substitutes based on (ESSENCE-1 & ESSENCE-2) trials involving >1500 patients
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Vevizye showed improved ocular surface health, with a reduction in corneal fluorescein staining at D15 (~71.6% responded within 4wks.); additional benefits were observed at up to 56wks., verifying its efficacy & tolerability
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Vevizye (CyclASol) is a clear, 0.1% ciclosporin solution without oils, surfactants, or preservatives offering superior spreading and longer retention on the eye
Product Name: Vyloy
Active ingredient: Zolbetuximab
Company: Astellas
Date: July 25, 2024
Disease: Gastric and Gastroesophageal Junction Cancer
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The CHMP has granted positive opinion to zolbetuximab + CT, with the decision anticipated in Oct 2024 & applicable across the whole EU plus Iceland, Liechtenstein & Norway. Other worldwide regulatory applications are under review
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Opinion was supported by 2 P-III studies assessing zolbetuximab plus mFOLFOX6 [SPOTLIGHT (n=565)] & CAPOX [GLOW (n=507)] vs PBO as a 1L treatment of HER2-ve & CLDN18.2+ve G/GEJ adenocarcinoma; published in The Lancet & Nature Medicine, respectively
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In addition, Astellas & Roche partnered for the VENTANA CLDN18 (43-14A) RxDx Assay, an immunohistochemistry-based companion diagnostic test, to find patients for zolbetuximab treatment. The test’s review is underway by the notified body
Product Name: Loqtorzi
Active ingredient: Toripalimab
Company: Junshi Biosciences
Date: July 25, 2024
Disease: NPC and ESCC
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The CHMP has granted positive opinion to 1L Loqtorzi with cisplatin & gemcitabine for recurrent, metastatic NPC as well as with cisplatin & paclitaxel for unresectable advanced, recurrent or metastatic ESCC; valid across the EU plus Iceland & Norway
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The opinions for NPC & ESCC were supported by P-III (JUPITER-02 & JUPITER-06) trials, respectively; JUPITER-02 results were highlighted at ASCO 2021 & published in Nature Medicine & JAMA, with JUPITER-06 results featured at ESMO 2021 & published in Cancer Cell & Journal of Clinical Oncology
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Toripalimab, an anti-PD-1 mAb, works by blocking PD-1 interactions with PD-L1 & PD-L2 ligands to improve endocytosis function
Related Post: Insights+: EMA Marketing Authorization of New Drugs in June 2024
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com