The FDA yesterday approved a novel drug from Otsuka to treat a chronic, autoimmune kidney disease.
The drug, called Voyxact, is part of an emerging class of drugs for IgA nephropathy, or IgAN, a disease caused by the build-up of immune antibodies in the kidneys. The condition, which leads to progressive loss of kidney function, can be addressed with existing drugs, but some patients still continue to decline and need new therapies with different modes of action.
Voyxact works by blocking a protein called A proliferation-inducing ligand, or APRIL. Vera Therapeutics and Vertex Pharmaceuticals are developing similar treatments.
Read more from STAT’s Adam Feuerstein.
| from Politico: |
| CMS CELEBRATES — The Trump administration is touting $12 billion in federal savings in Medicare’s second year of drug price negotiations, a figure that health officials say outdoes the program’s first-year savings under President Joe Biden, POLITICO’s David Lim reports.
On the list: The latest negotiations included Pfizer’s breast cancer therapy Ibrance, which 16,000 Medicare Part D beneficiaries used in 2024, and Boehringer Ingelheim’s lung fibrosis treatment Ofev, used by 24,000 people. The government reached a 50 percent discount on both of those drugs compared to their 2024 list prices. Novo Nordisk’s diabetes and weight-loss drugs yielded negotiated prices of $274 for Ozempic and Rybelsus and $385 for Wegovy for a 30-day supply for Medicare-covered conditions — a 71 percent discount from the 2024 list price. Nearly 2.3 million Medicare beneficiaries with prescription drug coverage used those drugs last year. That appears to be a higher number than the price President Donald Trump achieved earlier this month through a most-favored-nations deal with Novo Nordisk and Eli Lilly for their weight-loss drugs, which also impacts Medicare beneficiaries. The administration’s most-favored-nations campaign aims to secure commitments from drugmakers to bring U.S. prices of brand-name drugs in line with those paid in other high-income countries. However, how the two programs will interact is unclear. Why it matters: The agreed-upon prices will take effect in 2027 for the 15 drugs, saving people with Medicare prescription drug coverage an estimated $685 million in out-of-pocket costs. About 5.3 million Medicare beneficiaries used the drugs last year. Behind the scenes: The key factor in the second round of negotiations was the administration’s willingness to walk away from the table if they didn’t reach a deal, said Chris Klomp, deputy administrator of the Centers for Medicare and Medicaid Services, which handled the talks. Under the Inflation Reduction Act, without an agreement, a pharmaceutical manufacturer would likely need to withdraw its drugs from the Medicare and Medicaid programs — thereby losing access to programs that cover nearly 150 million Americans — or be punished with a high excise tax. “A true negotiation implies that you might not reach a negotiated outcome,” Klomp said. Key context: Health policy experts had predicted that the second round of price talks would yield greater savings for several reasons. More drugs were eligible for negotiation in the IRA program’s second year, and several of the 15 are pricey cancer drugs believed to have smaller rebates than other medicines, which could give CMS more room to extract deeper discounts. |
