Empagliflozin

Just days before the US Health Resources and Services Administration (HRSA) was set to launch a pilot evaluating a rebate-based model of the 340B discount programme, its rollout has been blocked by a federal judge.The American Hospital Association (AHA), along with the Maine Hospital Association and four safety-net hospitals, filed suit at the beginning of December to block the pilot's Jan. 1, 2026 launch, arguing that a rebate system "would inflict hundreds of millions of dollars’ worth of annual costs on hospitals." Judge Lance Walker of the US District Court for the District of Maine sided with the plaintiffs on Monday, issuing an injunction against the pilot as its "economic impact and disruption to services is substantial and… sufficient to demonstrate irreparable injury."Rebate pushCurrently, 340B-eligible hospitals — which serve uninsured and low-income patients — receive significant discounts on drugs upfront, but drugmakers have argued that the programme is rife with abuse, and that large hospital systems exploit the discounts by inflating prices for both uninsured patients and insurers. And for drugs set to debut lower Medicare prices next year thanks to negotiations under the Inflation Reduction Act (IRA), pharmaceutical companies are concerned their products may be subjected to duplicative price concessions if they are also purchased at the 340B price. To avoid potential abuse and "double-dipping," several pharmas, including Johnson & Johnson, Eli Lilly and Bristol Myers Squibb have pushed to adopt a model where hospitals would be required to pay the full amount of a drug upfront, then file for a rebate afterwards. Though their efforts to move to a rebate model were initially rebuffed, HRSA announced in July it would launch a pilot programme "to test…in a methodical and thoughtful approach…a fair and transparent 340B rebate model process." In October, nine therapeutics were accepted for the pilot, including three from J&J: Stelara (ustekinumab), an IL-12/IL-23 inhibitor approved for several autoimmune diseases; oral anticoagulant Xarelto (rivaroxaban); and blood cancer treatment Imbruvica (ibrutinib), which it co-commercialises with AbbVie. Other pilot participants include BMS's anticoagulant Eliquis (apixaban), Boehringer Ingelheim and Eli Lilly's diabetes and heart failure treatment Jardiance (empagliflozin), Merck & Co.'s diabetes drug Januvia (sitagliptin), Novo Nordisk's NovoLog family of insulin products, AstraZeneca's diabetes drug Farxiga (dapagliflozin), and Amgen's Enbrel (etanercept), which is used to treat chronic inflammatory diseases such as rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis. Each product selected for the 340B rebate model pilot was also part of the first round of Medicare price negotiations, which is also set to go into effect on Jan. 1, 2026.'Fatal' errorWhile the Administrative Procedure Act (APA) provides a pathway for US agencies to launch new programmes, it requires that the same be "reasonable and reasonably explained," with an agency tasked with keeping a "record of the relevant factors it considered and…a reasoned explanation for its course of action."However, Walker found that HRSA's rebate pilot did not meet these "vanishingly minimal requirements.""The Agency’s roll out has involved a rather threadbare administrative record that likely fails to consider and reasonably explain the impact of a rebate model on 340B hospitals, who rely on upfront price concessions to stretch few resources as far as possible to serve rural and poor communities," he wrote in his ruling. In the suit, AHA claimed that a rebate model would "impose vast administrative costs to submit, track, recover, and potentially dispute the rebates," while also draining hospitals "of huge sums of money through payments to drug companies that the hospitals then must wait to have refunded," and which drugmakers "have every incentive to slow and stymie the issuance of rebates." Walker took issue with the fact that HRSA is still evaluating administrative costs of its pilot. "This failure to consider administrative costs before approving the manufacturers’ applications under the Rebate Program is fatal under the APA," he concluded. "Defendants cannot fly the plane before they build it."

A new deal between Boehringer Ingelheim and Rectify Pharmaceuticals features an undisclosed mix of an upfront fee and milestones. \n Boehringer Ingelheim has opened another front in its attack on chronic kidney disease (CKD), offering Rectify Pharmaceuticals up to $448 million to partner on a preclinical program. The alliance positions Boehringer to work with Rectify on small molecules that enhance ABCC6 protein function. Research suggests variants in ABCC6, a transporter protein gene, are implicated in the vascular calcification seen in some CKD patients. Calcification is linked to cardiovascular morbidity and mortality and is seen in 80% of patients with end-stage kidney disease.Rectify identified the target as a good fit for its platform, which it built to address membrane protein dysfunction. The biotech’s pipeline features an ABCC6 program that is moving from candidate selection to IND-enabling studies. Rectify lists CKD and aortic valve stenosis as indications for the program.Boehringer has bet up to $448 million on Rectify’s ABCC6 work. The deal features an undisclosed mix of an upfront fee and preclinical, clinical, regulatory and commercial milestones. Typically, most of the value of such early-stage agreements is tied to later-phase development and commercialization. The deal also includes tiered royalties on future product sales. Søren Tullin, global head of cardiovascular-renal-metabolic diseases research at Boehringer, said in a statement that Rectify’s platform “offers a differentiated approach to developing disease-modifying treatments that target fundamental drivers of cardiorenal dysfunction.” Tullin added that enhancing ABCC6 function opens new possibilities in CKD and other diseases where calcification is a key pathology.The program strengthens Boehringer’s R&D activities in an important therapeutic area for the company. Jardiance, which Boehringer co-markets with Eli Lilly, won approval in CKD in 2023. Boehringer is also active in CKD drug development, with a study of the aldosterone synthase inhibitor vicadrostat among its roster of phase 3 trials. The drugmaker began enrolling the first of a planned 11,000 patients last year.Rectify launched in 2021 with $100 million. Backed by investors including Atlas Venture, the company set out to target a family of ABC transporters that previously had only played a role in the treatment of cystic fibrosis.