Borvo Medical Inc., a neurointerventional med-tech startup, reported U.S. FDA 510(k) clearance of its Endoport Vacuum Assisted Collection (EVAC) system, an alternative to traditional subdural hematoma (SDH) drainage methods. The EVAC system is expected to be available in early 2025 the company said.
The U.S. FDA has approved the second hemophilia drug in nearly six months from Pfizer Inc. This one, Hympavzi (marstacimab), is for preventing or reducing bleeding in those age 12 and older with hemophilia A and B. Hympavzi heralds a couple of market boundary breakers: it’s the first and only anti-tissue factor pathway inhibitor approved in the U.S. for hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered using a pre-filled, auto-injector pen.
The U.S. FDA’s device center disclosed its guidance ambitions for this new fiscal year – a list that includes the usual A and B lists for draft and final guidances. However, the agency now has an “under construction” list of guidance ambitions, the status of which is entirely reliant on the agency’s resources.
Genentech Inc. didn’t need to wait until Thanksgiving for the U.S. FDA to make up its mind. More than a month ahead of its PDUFA date, the agency approved the firm’s first-line breast cancer treatment, Itovebi (inavolisib), providing the oral therapy a place with other niched therapies from Astrazeneca plc and Novartis AG. Itovebi is to be combined with Pfizer Inc.’s palbociclib (Ibrance) and Faslodex (fulvestrant, Astrazeneca) for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer.
“This was worse than our national election,” Eric Peterson said as he explained his vote Oct. 10 concluding that Stealth Biotherapeutics Inc.’s elamipretide is effective in treating Barth syndrome, an ultra-rare mitochondrial disease that currently affects 129 males in the U.S. Peterson, a vice provost, senior associate dean and professor at the University of Texas Southwestern Medical Center, was one of 10 members of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) who came to that conclusion. Six others had a different opinion. Regardless of which way they voted, the panelists attested to how difficult the decision was.
The U.S. FDA has issued yet another complete response letter (CRL) for dasiglucagon, a glucagon receptor agonist, being developed by Zealand Pharma A/S for treating congenital hyperinsulinism, an ultra-rare disease that is also being targeted by at least two other companies. This CRL is pegged to the timing of a third-party manufacturing facility reinspection that was done in August and September. The agency also wants some additional clinical analysis from the phase III study.
The U.S. FDA gave the 510(k) green light to Echo IQ Ltd.’s Echosolv AS for its AI-enabled software as a medical device to be used as a decision support aid in detecting severe aortic stenosis.
Antag Therapeutics ApS has received IND clearance from the FDA for lead molecule, AT-7687. A phase I trial will evaluate AT-7687 in healthy lean and healthy obese subjects, including as monotherapy and in combination with semaglutide in the healthy obese individuals.
Stealth Biotherapeutics Inc. had hoped the U.S. FDA would have approved its lead candidate, elamipretide, as the first treatment for Barth syndrome by now. Instead, it’s headed to a meet-up with the agency’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Oct. 10. The discussion and vote at that meeting could be make-or-break for patients with the ultra-rare debilitating mitochondrial disease that has no approved therapies. “Barring support from CRDAC, the future of elamipretide for Barth syndrome in the U.S. is tenuous," Stealth CEO Reenie McCarthy told BioWorld.
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