AstraZeneca

The FDA approved benralizumab (Fasenra) for eosinophilic granulomatosis with polyangiitis (EGPA), based on the MANDARA phase 3 trial comparing it with mepolizumab. The study involved 140 patients, with 99% completing benralizumab treatment and 96% mepolizumab. Common adverse events included COVID-19, headache, and arthralgia, with no deaths reported. Benralizumab offers a new treatment option for EGPA patients, potentially reducing reliance on corticosteroids.

Benralizumab approved by FDA for EGPA treatment based on MANDARA trial data, showing noninferiority to mepolizumab in achieving remission and reducing steroid dependence.

AstraZeneca's FASENRA® (benralizumab) approved in the US for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Approval based on MANDARA Phase III trial results, showing FASENRA's efficacy and safety comparable to mepolizumab. FASENRA helps patients achieve remission and taper off oral corticosteroids.

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis; MANDARA trial showed nearly 60% of patients achieved remission and 41% fully stopped taking oral corticosteroids.

The FDA approved Fasenra based on the MANDARA Phase III trial, showing its efficacy and safety in EGPA patients, with nearly 60% achieving remission and 41% tapering off oral corticosteroids.

PD-1 inhibition with pembrolizumab before and after surgery significantly improves 5-year overall survival (86.6% vs 81.7%) in high-risk early triple-negative breast cancer, according to KEYNOTE-522 trial results.

Enhertu (trastuzumab deruxtecan) demonstrated significant overall and intracranial clinical activity, including prolonged PFS, in HER2-positive mBC patients with brain metastases in the DESTINY-Breast12 trial. The findings support Enhertu's potential as a second-line treatment, with a 12-month PFS rate of 61.6% and CNS PFS rate of 58.9% among patients with brain metastases.

Daiichi Sankyo and Merck's antibody-drug conjugate, patritumab deruxtecan, met Phase 3 trial goals, delaying EGFR-mutated non-small cell lung cancer progression better than chemotherapy. The drug uses an antibody to target tumor cells and release a toxic chemical. Daiichi has six ADCs using deruxtecan chemotherapy, including Enhertu, with sales of $1.8 billion in H1 2024. Merck's $22 billion deal with Daiichi aims to bolster its pipeline as Keytruda patents near expiration.

FDA approves Sanofi and AstraZeneca's new filling line for Beyfortus, enabling expanded manufacturing capacity and supply in the U.S. for the 2024/2025 RSV season. Beyfortus, a long-acting antibody, was FDA-approved in July 2023 for infants and children up to 24 months old at severe risk of RSV infection. CDC analysis in March 2024 showed Beyfortus 90% effective at preventing RSV hospitalization.