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Drug approvals in Europe| EMA drug approvals | 2023 |European Commission News| iPharmaCenter

Bristol Myers Squibb's Reblozyl (luspatercept) has received approval from the European Commission for treating anemia in adult patients with non-transfusion-dependent beta-thalassemia.

This approval is based on Phase 2 BEYOND study results, in which Reblozyl was tested for efficacy in 145 patients with NTD beta-thalassemia. The study's primary endpoint was ≥1.0 g/dL mean Hb increase from baseline, in which 77.1% of patients met the primary endpoint versus 0% in patients on placebo. A mean Hb increase of ≥1.5 g/dL from baseline between Weeks 37-48 was included as a key secondary endpoint; 49% of patients achieved met the endpoint versus 0% of patients on placebo.

Reblozyl binds to TGF-beta superfamily ligands, diminishing Smad2/3 signaling and helping patients produce healthy red blood cells. The US FDA previously approved it for treating anemia in patients with beta-thalassemia who require regular red blood cell transfusions and anemia failing an erythropoiesis-stimulating agent.

Reblozyl is developed through a collaboration between BMS and Merck.


Bayer announced that European Commission approved Nubeqa (darolutamide) for treating adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Previously, it was approved for non-metastatic castration-resistant prostate cancer (nmCRPC) who were at risk of developing metastatic disease.

The approval was based on the Phase III ARASENS trial. The combination of Nubeqa, ADT, and docetaxel significantly reduced the risk of death by 32.5% versus ADT plus docetaxel combination. The adverse events were similar in both treatment arms.

Bayer and Orion Corporation developed Nubeqa.


AstraZeneca announced that Enhertu (trastuzumab deruxtecan) was approved in the European Union (EU) as monotherapy in patients with unresectable or metastatic HER2-low breast cancer. It is indicated in patients who received prior chemotherapy.

The approval was based on the DESTINY-Breast 04 trial, in which Enhertu reduced the risk of disease progression or death by 50%. The overall survival was increased by six months versus chemotherapy. The progression-free survival was 9.9 months in patients on Enhertu versus 5.1 months in patients on chemotherapy. The risk of death was reduced by 36%, with median overall survival of 23.4 months versus 16.8 months in patients on chemotherapy.

In March 2019, Daiichi Sankyo and AstraZeneca entered a collaboration to develop and commercialise Enhertu.


Roche announced that the European Commission approved Xofluza (baloxavir marboxil) for treating children aged one year and older, uncomplicated influenza, and post-exposure prophylaxis.

The approval was based on two Phase 3 trials, miniSTONE-2 and BLOCKSTONE. In the miniSTONE-2 trial, Xofluza reduced the length of time of influenza release versus oseltamivir (24.2 hours versus 75.8 hours).

In the BLOCKSTONE study, Xofluza showed a significant prophylactic effect versus placebo (1.9% in patients treated with Xofluza versus 13.6% in patients on placebo).

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