Two roxadustat partners AstraZeneca and FibroGen have received objections regarding safety concerns of their drug from the FDA after which the two companies headed into a high-stakes meeting with the FDA staffers. The daylong session didn’t have a fruitful response, rather, their application faced even more uncertainty.
The meeting was held to discuss the drug’s safety profile and efficacy in both non- dialysis patients and patients having dialysis and their enrollment criteria for clinical research ̶ a potential post-marketing study.
FDA committee panelists disapproved the use of the said drug for treating anemia in chronic kidney disease non-dialysis patients by 13 to 1 vote. The committee raised questions about the entirety of the safety data provided by the companies. The panelists were unsure about the post-marketing study proposed by the partner company to learn about drug’s heart safety profile.
The only vote in their favour was of Dr. Susan Crowley from Veterans Health Administration, who said that it would be fair for patients and providers to share the responsibilities of decision-making under a risk-mitigation program.
The panelists voted 2 to 12 against the approval for patients with dialysis, and this particular vote, other than Crowley’s, which turned to “yes” in this matter, was of Dr. Ravi Thadani, from Mass General Brigham. He was with the viewpoint that some people could get benefit from the treatment and also that he was “convinced” by the efforts put in by AstraZeneca and FibroGen for taking safety concerns seriously.
The center of discussion throughout the meeting was the drug’s safety and data provided by the companies. The panelists concluded that the companies must provide more safety data before the drug becomes commercially available.
The vote from the FDA’s advisory committee sets up high-stakes FDA review for the drug. The agency isn’t bound to adhere to the recommendations of its committee, but it usually does.
Talking particularly about roxadustat, AstraZeneca FDA had scheduled its decision regarding the drug back in December, 2020, but later extended its decision to March, 2021. Then in March, the agency further delayed the process by saying that an advisory committee meeting must be convened.
In addition to back-to-back delays, the two companies hit another setback in April when one of the partners, FibroGen, declared that it had modified the criteria for analysing heart safety data for roxadustat to be more convenient.
The drug is already commercially available in China and Japan.
The industry watchers have already believed that the drug would be a blockbuster beating standard erythropoiesis stimulating agents in the race with an additional benefit of treating non-dialysis patients.
