Astellas is focused on maximizing the VALUE of its main products, XTANDI and Betanis/Myrbetriq/BETMIGA, and new products, XOSPATA, Evrenzo and PADCEV.
Prostate Cancer Treatment
XTANDI is an androgen receptor signaling inhibitor indicated for the treatment of forms of advanced prostate cancer in different countries.
Since being launched in the United States in 2012, XTANDI is now available around the world, including in Europe, Japan and Asia.
Since its launch, it has obtained additional indications for the earlier stages of prostate cancer and has contributed to the treatment of many patients.
With a strong presence in the urological field and by leveraging abundant data based on accumulated clinical experience since its launch, Astellas aims for a further penetration of approved indications.
Acute Myeloid Leukemia (AML) Treatment
XOSPATA is a FLT3 inhibitor for adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation-positive. It was launched in Japan and the United States in December 2018 and in Europe in November 2019.
AML is a cancer that affects the blood and bone marrow, and about 30% of the patients are reported to have mutations in the protein FLT3, a receptor tyrosine kinase involved in the growth of cancer cells. XOSPATA is believed to inhibit the growth of tumor cells bearing FLT3 mutations by showing inhibitory activity against mutations in both internal tandem duplication mutations (Internal Tandem Duplication: ITDs) and tyrosine kinase domain mutations (Tyrosine Kinase Domain: TKDs), which are activating mutations in FLT3.
Astellas contributes to the treatment of AML by providing XOSPATA as a new treatment option for FLT3m+ relapsed or refractory AML patients and healthcare professionals.
Metastatic Urothelial Cancer Treatment
PADCEV (enfortumab vedotin-ejfv), a treatment for adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1, and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting, was launched in the United States in December 2019.
PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells. Nonclinical data suggest that the anticancer activity of PADCEV is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalization of the ADC-Nectin 4-complex and release of MMAE via proteolytic cleavage. Release of MMAE disrupts the microtubule network within the cell subsequently inducing cell-cycle arrest and apoptotic cell death.
Metastatic urothelial cancer is a serious disease with limited treatment options. Astellas will contribute to the treatment of metastatic urothelial cancer by providing PADCEV as a treatment option in the United States for adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1, and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. In addition to the Unites States, we and Seattle Genetics are advancing the development of PADCEV in Japan, Europe, and other countries worldwide.
Overactive Bladder (OAB) Treatment
Betanis/Myrbetriq/BETMIGA for the treatment of OAB is a beta-3 adrenergic receptor agonist. Since the first launch in Japan in 2011 under the brand name of Betanis, the product has since been launched as Myrbetriq in the Americas, and BETMIGA in Europe and Asia & Oceania.
The drug improves various symptoms associated with OAB, such as urgency, urinary frequency, and urge urinary incontinence, through a new mode of action.
Astellas aims to maximize its product VALUE by ensuring that more physicians understand the balance between efficacy and tolerability, the feature of this product.
Renal Anemia Treatment
Evrenzo is an oral, first-in-class treatment for anemia associated with chronic kidney disease (CKD). In November 2019, it was launched in Japan for the treatment of anemia in adult CKD patients that are dialysis dependent (DD). Additionally, in January 2020, we submitted a supplemental application to the Pharmaceuticals and Medical Devices Agency (PMDA) for approval of an additional indication of anemia associated with CKD in adults who are non-dialysis dependent (NDD).
Evrenzo is an inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), which is different from that of erythropoiesis-stimulating agents (ESAs). As a HIF-PH inhibitor, Evrenzo activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. This response involves the regulation of multiple, complementary processes to promote erythropoiesis and to increase the blood’s oxygen-carrying capacity.
As a new treatment option for adults with CKD anemia in the dialysis phase, where unmet medical needs still exist, the drug will further contribute to patients with CKD anemia and healthcare professionals involved in its treatment. In addition to Japan, it is under development in Europe and elsewhere.
Prograf and Advagraf/Graceptor/ASTAGRAF
Prograf and Advagraf/Graceptor/ASTAGRAF are immunosuppressants used to suppress organ rejection following a transplant. Although the patent for this drug has already expired in major countries, it continues to be used in transplants globally, and contributes to the treatment of autoimmune diseases such as rheumatoid arthritis and ulcerative colitis in Japan.
Other Main Products
OAB treatment: Vesicare
Prostate cancer treatment: Eligard
Benign prostatic hyperplasia treatment: Harnal/Omnic
Antifungal agent: Funguard/MYCAMINE
Please refer to the Supplementary Documents (pdf) of the Business Results in regard to the sales of major products in each region, including the products above.