The potential for psychedelics to deliver long-lasting benefits for people with anxiety, depression, post-traumatic stress disorder and addiction is being put to the test in Australia, where new research and discovery centers are adding to a global enterprise of nearly 100 clinical trials underway in the space.
The U.S. FDA declined to approve Gilead Sciences Inc.’s Hepcludex (bulevirtide), issuing a complete response letter (CRL) citing manufacturing and delivery concerns for the antiviral aimed at treating confirmed chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Acquired in Gilead’s 2021 buyout of Myr GmbH, Hepcludex received conditional approval from the European Commission in 2020 and would have been the first drug cleared for HDV in the U.S. Its delay, however, could give a boost to Eiger Biopharmaceuticals Inc., which is expected to report phase III data for lonafarnib by the end of 2022.
Skeptical briefing documents pertaining to the U.S. FDA’s adcom meeting on Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) turned out predictive of the less-than-happy outcome, as the regulator’s Oncologic Drugs Advisory Committee (ODAC) turned thumbs down on the prospective drug for pediatric central nervous system/leptomeningeal metastasis from neuroblastoma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avrobio, Diamedica, Dyadic International, ITM Isotope Technologies München, Myeloid, Novo Nordisk, Reveragen, Santhera, Simcere.
A U.S. FDA advisory panel saw a number of problems in the clinical trial for the Avertd test for opioid use disorder (OUD), including the fact that the study failed to enroll a sufficiently ethnically diverse body of subjects. Perhaps more damning was that the advisory panel was uncertain as to whether the 15 single nucleotide polymorphisms (SNPs) evaluated in the test were helpful in sorting out which patients were truly at high risk of OUD, leading to an 11-2 vote that the probable benefits of the test do not outweigh the risks.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Astrazeneca, Beigene, Cellevolve, Cour, Hugel, Ipsen, Janssen, Novaccess, Petros, Seres.
Briefing documents related to the Oct. 28 meeting of the Oncologic Drugs Advisory Committee (ODAC) to deliberate over Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) took aim at the company’s ongoing, pivotal experiment called Study 101, data from which the company highlighted in early October.
The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma (MM), joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies.
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.
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