GSK plc may have pushed the door open Oct. 26 for the use of a new class of oral drugs to treat anemia in U.S. patients with chronic kidney disease who are dialysis dependent. The U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13-3 that the benefits of GSK’s daprodustat outweighed the risks in that population. However, the committee didn’t push the door wide enough for patients not on dialysis, voting 5-11 on the question of whether the drug’s benefits outweighed its risk in the nondialysis population, even though that group conceivably could see a greater benefit. The test now is whether the FDA will follow the committee’s lead.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nervgen, Regenerx, Rznomics, Timber.

Device makers often need the assistance of physicians to aid in device design and development, but this is a practice that comes with some legal hazards. A session held here in Boston on enforcement in the U.S. made clear that manufacturers must exercise caution in these consulting arrangements, such as documenting the need for outside help with the device, lest the manufacturer end up with a hefty, multimillion-dollar fine imposed by U.S. enforcement agencies.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Astrazeneca, Biontech, Carsgen, GSK, Kira, Moderna, Novavax, Pfizer, Roche, Telix, Zhiyu.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acumen, Astrazeneca, Daiichi, JJP, Leo, Merck & Co., Novaliq, Novavax, Sensorion, Vanda, Vaxxinity.

The U.S. FDA recently released its guidance agenda for fiscal 2023, a plan that de-emphasizes the oft-promised draft guidance for change control for artificial intelligence (AI) algorithms, which is listed as a B priority instead of an A draft guidance priority. At this year’s Medtech Conference here in Boston, the FDA’s Melissa Torres disavowed the notion that any national regulatory authority is delaying another authority’s policy on software change control, but she acknowledged that these conversations about regulatory harmonization typically predate formal policy development.

Hoping its drug, daprodustat, can succeed in the U.S. where two other hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) have failed so far, GSK plc will present its case Oct. 26 to the FDA’s Cardiovascular and Renal Drugs Advisory Committee for the drug's potential use as a treatment for anemia in patients with chronic kidney disease regardless of dialysis dependency.