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Eli Lilly
NEWS

Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer’s Disease 

Shots:   The approval of Kisunla (350mg/20mL, IV, QM) for early symptomatic Alzheimer's disease was based on P-III (TRAILBLAZER-ALZ 2) study. Coverage & reimbursement is available through National Coverage Determination with Coverage with Evidence Development  The P-III (TRAILBLAZER-ALZ 2) trial assessed Kisunla vs PBO in patients (n=1,736) with early symptomatic AD (MCI or mild dementia) &…
July 2, 2024

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NEWS

Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea) 

Shots:  The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO)  The approval was based on analytical, pre-clinical, clinical and manufacturing data…
June 28, 2024

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NEWS

Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea) 

Shots:  The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO)  The approval was based on analytical, pre-clinical, clinical and manufacturing data…
June 28, 2024

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Verona Pharma
NEWS

Verona Pharma’s Ohtuvayre (Ensifentrine) Receives the US FDA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD) 

Shots:  The US FDA has approved Ohtuvayre as a maintenance therapy to treat COPD patients, with its launch anticipated in Q3’24  The approval was based on the P-III (ENHANCE-1 & ENHANCE-2) studies analyzing Ohtuvayre monotx. or in addition with other maintenance therapies. Trials reached their 1EPs showing improved lung function; results were published in the…
June 26, 2024

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Botanix
NEWS

Botanix Pharmaceuticals’ Sofdra (Sofpironium) Receives the US FDA’s Approval to Treat Primary Axillary Hyperhidrosis 

Shots:  The US FDA has granted approval to Sofdra gel (12.45%) for the treatment of adults & children (≥9yrs.) with primary axillary hyperhidrosis  The approval was based on the two pivotal P-III (CARDIGAN) trials assessing the efficacy & safety of Sofdra vs vehicle in primary axillary hyperhidrosis patients (n=701). Trials reached its 1EPs & 2EPs…
June 20, 2024

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Ipsen
NEWS

Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis 

Shots:  The US FDA has granted accelerated approval to Iqirvo (80mg tablets) in addition to ursodeoxycholic acid (UDCA) to treat PBC adults having inadequate response to UDCA or as monotx. in UDCA intolerant patients. Full approval depends on (ELFIDENCE) confirmatory trial  The approval was based on a P-III (ELATIVE) study assessing the safety & efficacy…
June 10, 2024

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Geron
NEWS

Geron’s Rytelo (Imetelstat) Gains the US FDA’s Approval to Treat Myelodysplastic Syndromes (MDS) with Transfusion-Dependent Anemia 

Shots:  The US FDA has approved Rytelo to treat low- to intermediate-risk MDS with transfusion-dependent (TD) anemia adults who did not respond to, lost response, or are not eligible for erythropoiesis-stimulating agents (ESA)  The approval was supported by the P-III (IMerge) study of Rytelo vs PBO, depicting a 39.8% vs 15.0% RBC-TI rate for 8wks.…
June 6, 2024

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VIEWPOINTS_Donna Carstens_2024
VIEWPOINTS

SEA Management: Donna Carstens from AstraZeneca in a Riveting Conversation with PharmaShots

Shots:  Recently AstraZeneca’s FASENRA (benralizumab) received approval from the US FDA as an add-on maintenance treatment for patients (≥ 6 yrs.) with severe asthma and with an eosinophilic phenotype  Today, at PharmaShots we have with us Donna Carstens, Senior Medical Director Respiratory, Fasenra at AstraZeneca  Donna shares insights from the TATE study an open-label, multinational,…
June 3, 2024

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