New research presented by the University of Michigan revealed groundbreaking results for Certa Therapeutics Pty Ltd.’s lead candidate, FT-011, for serious inflammatory and fibrotic diseases. The results of a chronic kidney disease study presented at the American Society of Nephrology meeting on Nov. 4 concluded that FT-011 reverses the activation of molecular markers associated with fibrosis.
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.
Sumitovant Biopharma Ltd., a subsidiary of Sumitomo Pharma Co. Ltd., agreed to acquire Myovant Sciences Ltd. for $27 per share, up from its earlier offer of $22.75 per share. The deal is worth $1.7 billion on a fully diluted basis, with an equity value of about $2.59 billion.
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.
Higher-than-expected serum bicarbonate values in the placebo group foiled Tricida Inc.’s effort in its phase III renal outcomes trial to compare an untreated acidotic chronic kidney disease (CKD) population with those given veverimer. The hitch meant the company could not measure the oral, non-absorbed polymer’s ability to slow the disease in patients with metabolic acidosis, an estimated market of several million people in the U.S.
Sumitovant Biopharma Ltd., a subsidiary of Sumitomo Pharma Co. Ltd., agreed to acquire Myovant Sciences Ltd. for $27 per share, up from its earlier offer of $22.75 per share, which Myovant had rebuffed. The deal is worth $1.7 billion on a fully diluted basis, with an equity value of about $2.59 billion.
In a bit of déjà vu, the U.S. FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee once again voted that Makena (hydroxyprogesterone caproate) should be withdrawn from the U.S. market while a second confirmatory trial is designed and conducted. But this time around, the committee’s 14-1 vote was much more decisive than its 9-7 vote in 2019.
Nearly one year after CSL Ltd. announced its $11.7 billion acquisition of Vifor Pharma Ltd., the company outlined for the first time the synergies of the two companies and its long-term growth strategy aimed at the nephrology market.
The FDA’s Center for Drug Evaluation and Research (CDER) came out punching Oct. 17 at the start of a three-day hearing before the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on whether Covis Pharma BV’s Makena (17-hydroxyprogesterone caproate), a branded version of a drug that’s been used since 1956 to prevent preterm births, should be withdrawn from the market.
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