Roxastatin: New plan to enter United States fails again
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Roxastatin: New plan to enter United States fails again
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Roxastatin: New plan to enter United States fails again.
In the U.S., Roxadustat, an oral anemia drug imported by Fibro, is dying in the marketing application process, and is now on the verge of despair!
FibroGen developed a new plan for the US launch of roxadustat after the US Food and Drug Administration (FDA) rejected its marketing application for the chronic kidney disease (CKD) indication. Now, that dream is also shattered.
On May 5, FibroGen announced that a phase 3 clinical study of roxadustat in the treatment of anemia in patients with transfusion-dependent low-risk myelodysplastic syndrome (MDS), MATTERHORN, failed to meet its primary efficacy endpoint.
Numerically, roxadustat outperformed placebo. Among patients taking Fibrogen, 47.5 percent did not require blood transfusions for at least 56 consecutive days during the 28-week trial period. In contrast, 33.3% of patients in the control group achieved transfusion independence.
FibroGen has not disclosed any regulatory plans following the failed trial. Even when an application is considered, the FDA may not approve a drug based on a failed trial.
The trial failure puts FibroGen’s U.S. partnership with AstraZeneca in serious jeopardy. MDS has been FibroGen’s U.S. rescue program for roxadustat after the FDA rejected the drug in 2021 for treating CKD-related anemia. The companies have since been unable to agree on funding a new trial to support another CKD application in the US.
FibroGen and AstraZeneca tied the knot on rosacea back in 2013. According to FibroGen’s safety filing, the agreement provides AstraZeneca with the right to terminate the deal in the event of negative clinical results and other development, regulatory or commercialization setbacks.
Roxadustat belongs to the new class of oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI), which once brought huge market expectations, and some experts believe that it can replace erythropoiesis-stimulating agents (ESAs), which Infusion or injection is required. But a series of safety concerns pointed out by the FDA, including blood clots and serious infections, eventually led to a crackdown by regulators.
Meanwhile, rival GlaxoSmithKline’s drug Jesduvroq (daprodustat) was the first to win FDA approval in February for dialysis-dependent patients with CKD.
And Akebia Therapeutics is appealing the 2022 FDA rejection of vadadustat.
Roxastat, meanwhile, hasn’t had much success outside the United States. The drug brought in $61 million in sales for AstraZeneca in the first quarter as China approved the drug for both dialysis and non-dialysis patients.
Astellas, which owns rights to roxadustat (Evrenzo) in Japan and Europe, just recorded a 47 billion yen ($348 million) impairment charge based on lower-than-expected sales forecasts for the drug.
In Japan, competition in the HIF-PHI category is fierce given that three drugs of the same class have been approved in Japan. Astellas CEO Naoki Okamura told investors on a conference call last week that in Europe, roxadustat failed to show an advantage over existing ESAs (erythropoiesis-stimulating agents).
Roxas’ failure in MDS was also good news for Bristol-Myers Squibb. Bristol-Myers Squibb’s Reblozyl (luspatercept-aamt) won FDA approval in 2020, making it the first new MDS treatment option in more than a decade. Reblozyl, as an erythrocyte maturation agent, helps patients reduce the burden of erythrocyte transfusion by regulating the later stages of erythrocyte maturation.
Roxastatin: New plan to enter United States fails again
(source:internet, reference only)
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