Astellas Beats Rivals To Japan HIF-PHI Market As Roxadustat Launched
Executive Summary
Astellas becomes first to market in Japan in new class of oral anemia drugs, beating multiple rivals in a sector set to see strong growth but also fierce competition.
Following an approval in September, Astellas Pharma Inc. has launched in Japan the novel oral anemia drug roxadustat, making it the first in the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) class to reach the market in the country.
The first-in-class molecule, discovered by and licensed from FibroGen Inc., was listed in the national health insurance system’s reimbursement tariff on 19 November and launched the following day, as Evrenzo, for the treatment of renal anemia associated with chronic kidney disease (CKD) in patients on dialysis.
The launch positions Astellas well in a potentially large market. There are around 13 million people with chronic advanced CKD in Japan, with about 10% of those with Stage 3-5 CKD also having renal anemia, a situation that increases the rate of progression to renal failure and the likelihood of cardiovascular complications.
The number of patients on dialysis in Japan is increasing steadily, exceeding 330,000 in 2017.
Intravenously administered erythropoiesis-stimulating agents (ESAs) are currently the standard of care for anemia in CKD, and the HIF-PHIs will provide a new and more convenient once-daily oral option.
Datamonitor Healthcare is currently predicting sales of $564m for roxadustat in Japan in the 2024 and says that it “has the potential to become the new standard of care for anemia in CKD, on account of its superior safety, cost-efficiency, and reduced need for iron supplements compared to ESAs.”
But multiple rivals are snapping at Evrenzo’s heels, the closest of which look set to reach the market potentially within the next year. The nearest of these appears to be Mitsubishi Tanabe Pharma Corp.’s vadadustat (MT-6548; licensed from Akebia Therapeutics Inc.), for which the first approval filing globally was made in Japan in July. (Also see "Vadadustat Emerges As Japan HIF-PHI Contender With First Filing Globally " - Scrip, 23 Jul, 2019.)
Evrenzo has been launched in 20mg, 50mg and 100mg tablet formulations, reimbursed at JPY387.40 ($3.58), JPY819.20 and JPY1,443.50 per tablet respectively. For adult patients not receiving ESAs, the usual starting dosage is 50mg three times weekly. Thereafter, this should be adjusted according to the patient’s condition but not exceeding 3.0mg/kg. In adult patients switching from ESAs, the usual starting dose is 70mg or 100mg three times weekly, adjusted according to the patient’s condition but not exceeding 3.0mg/kg.
Outside Japan, Astellas’s alliance with FibroGen extends to other markets including the EU, CIS and Middle East and South Africa. FibroGen is partnering with AstraZeneca PLC for China, the US and other selected markets and roxadustat received its first approval globally in China (for use in both dialysis-dependent and non-dependent CKD patients) earlier this year. (Also see "First Approval For AZ's Roxadustat With China Green Light " - Scrip, 18 Dec, 2018.)
Japan Rivals
Elsewhere in the HIF-PHI sector in Japan and in addition to vadadustat, Japan Tobacco Inc. and commercial subsidiary Torii Pharmaceutical Co. Ltd. have said they are planning a Japanese filing for their candidate enarodustat following positive top-line Phase III results, but the exact timing of this remains unclear.
GlaxoSmithKline PLC/Kyowa Hakko Kirin Co. Ltd.’s daprodustat is also in Phase III in Japan, with an approval application expected sometime this year.
Astellas is also conducting Phase III trials in Japan with roxadustat for the additional indication of renal anemia in patients not receiving dialysis, an approval that could significantly expand the potential market for the product.
AstraZeneca and Fibrogen recently reported positive data in this set of patients. (Also see "Clear Path For AstraZeneca’s Roxadustat After Reassuring Safety Data" - Scrip, 11 Nov, 2019.)
Globally, roxadustat is also in Phase III in the US and Europe and in Phase II/III in China for anemia associated with myelodysplastic syndromes and Phase II development is underway for chemotherapy-induced anemia.
Globally in all indications, analysts have predicted that expanded use in these settings could eventually generate blockbuster sales of $1.4bn for the molecule by 2024.