ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma announced FDA approval of Myrbetriq (mirabegron) for treating neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older, weighing at least 35 kg. This includes two formulations: Myrbetriq extended-release tablets and Myrbetriq Granules, the latter set for U.S. availability by the end of 2021. The approval also grants an additional six months of market exclusivity. NDO is often linked to spina bifida, affecting urinary control. This approval reflects Astellas' commitment to enhancing urologic health for vulnerable populations.

Astellas Pharma has received a positive opinion from the European Medicines Agency's CHMP for XTANDI (enzalutamide) to treat metastatic hormone-sensitive prostate cancer (mHSPC). This oral therapy addresses a significant unmet medical need, as mHSPC has a median survival of about 3-4 years. If approved by the European Commission, enzalutamide will be the only oral treatment for three types of advanced prostate cancer. The decision is based on favorable results from the Phase 3 ARCHES trial, where enzalutamide plus androgen deprivation therapy significantly reduced the risk of disease progression.

Astellas Pharma and Seagen announced the acceptance of a marketing authorization application (MAA) for **enfortumab vedotin** by the **European Medicines Agency (EMA)** for treating advanced urothelial cancer. This therapy is aimed at adults who have previously undergone treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. If approved, it will be the first **antibody-drug conjugate (ADC)** available in the European Union for this condition. The MAA is based on the **global phase 3 EV-301 trial**, which showed promising results compared to chemotherapy.

Astellas Pharma announced positive topline results from the Phase 3 SKYLIGHT 1 and SKYLIGHT 2 trials for fezolinetant, a nonhormonal treatment for moderate to severe vasomotor symptoms (VMS) in menopausal women. Both trials demonstrated significant reductions in the frequency and severity of VMS compared to placebo. Serious treatment-emergent adverse events were minimal. These studies are crucial for evaluating the safety of fezolinetant over 52 weeks, with detailed results forthcoming. If approved, fezolinetant would be a first-in-class option for VMS.

Astellas and Seagen have completed submissions for two supplemental Biologics License Applications (sBLAs) to the FDA for PADCEV (enfortumab vedotin-ejfv). One seeks to convert its accelerated approval to regular approval based on the EV-301 trial data, while the second aims for label expansion to include patients with metastatic urothelial cancer previously treated with a PD-1/L1 inhibitor. The FDA is reviewing these applications under the Real-Time Oncology Review pilot program, which aims for expedited access to effective treatments.

Astellas Pharma and Seagen announced positive primary results from the phase 3 EV-301 trial for PADCEV in adult patients with advanced urothelial cancer. The trial showed that patients receiving PADCEV had a median overall survival of 12.9 months, 3.9 months longer than those on chemotherapy (9.0 months). Secondary endpoints also favored PADCEV, with a median progression-free survival of 5.6 months. The findings highlight PADCEV as the first therapy to significantly reduce the risk of death compared to chemotherapy in this patient demographic. Results will be submitted to the FDA and global health authorities.

Astellas Pharma and Seagen announced results from the pivotal phase 2 EV-201 trial, where 52% of patients treated with PADCEV (enfortumab vedotin-ejfv) exhibited an objective response. Among these, 20% achieved a complete response, and the median duration of response was 10.9 months. This trial focused on patients with locally advanced or metastatic urothelial cancer who were ineligible for cisplatin chemotherapy. The findings, presented at the ASCO GU symposium, will be submitted to the FDA by the end of March as part of a supplemental biologics licensing application.

Astellas Pharma has received conditional approval from China's NMPA for XOSPATA (gilteritinib) to treat adult patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations. This expedited approval follows priority review status granted in July 2020. Gilteritinib addresses a critical need, as approximately 30% of AML patients have FLT3-ITD mutations, linked to poor prognosis. The approval is based on the Phase 3 ADMIRAL trial, showing gilteritinib increased median overall survival to 9.3 months compared to 5.6 months with traditional chemotherapy.

Astellas Pharma announced the presentation of 42 roxadustat abstracts at the ASN Kidney Week 2020, in collaboration with FibroGen and AstraZeneca. Key findings include the Phase 3 DOLOMITES study and a Japanese Phase 3 study comparing roxadustat and darbepoetin alfa for treating anemia in CKD patients not on dialysis. Roxadustat is under regulatory review in Japan, the U.S., and EU for CKD-related anemia treatments. The data presented aims to demonstrate the efficacy and safety of roxadustat in diverse patient populations.