Rivaroxaban

Keytruda racks up another approval, this time in ovarian cancersFDA will rule on oveporexton in the third-quarterBiocodex picks up two rare disease programmes from THX PharmaRivaroxaban combo axed from major US stroke trialKeytruda racks up another approval, this time in ovarian cancersThe FDA on Tuesday approved both the infused and subcutaneous formulations of Merck & Co.'s Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, to treat adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express PD-L1 and who have received one or two prior systemic treatment regimens. While the PD-1 inhibitor brought in more than $30 billion in sales last year, it's rapidly approaching a 2028 patent expiration (see – Spotlight On: Merck & Co.'s fastest selling drugs in 2025).The approval was based on findings from the Phase III KEYNOTE-B96 trial, the first time an immunotherapy-based regimen has shown such a broad benefit in the specific patient population. In patients with PD-L1–positive tumours, the Keytruda regimen led to median progression-free survival of 8.3 months and median overall survival of 18.2 months; the placebo arm saw a benefit of 7.2 months and 14 months, respectively. Alongside Keytruda's approval, the FDA cleared the PD-L1 IHC 22C3 pharmDx test from Agilent Technologies as a companion diagnostic to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express PD-L1 and may be eligible for treatment.-Elizabeth EatonFDA will rule on oveporexton in the third-quarterAn application for Takeda's oral narcolepsy candidate was granted priority review on Tuesday, with a PDUFA date penciled in for the third quarter. Oveporexton (TAK-861) stands to become the first orexin agonist approved for narcolepsy type 1 (NT1) (see – ViewPoints: With oveporexton at the helm, Takeda’s orexin push gains steam).In July, the Japanese pharma reported that oveporexton met all primary and secondary goals in a pair of Phase IIl NT1 trials, and at the World Sleep conference in September shared detailed results showing that the majority of participants treated with a 2-mg dose achieved "normal" wakefulness (see – Spotlight On: Narcolepsy win provides more pipeline momentum for Takeda).The data were well received by physicians. A FirstWord survey fielded to neurologists found that more than half are very likely to prescribe oveporexton if it is approved (see – Physician Views Results: Strong prescriber interest suggests oveporexton could awaken orexin’s long-awaited potential)And that approval is looking likely. An expert told FirstWord that there is "no way" that regulators could refuse oveporexton because it "is the first drug that seems to work on all the symptoms and right from the start, and can completely change the life of a patient." For further feedback, see KOL Views Q&A: Takeda’s oveporexton is raising the bar for narcolepsy drugs, rival orexin agonists.-Elizabeth EatonBiocodex picks up two rare disease programmes from THX Pharma Biocodex padded its pipeline on Tuesday, thanks to a pair of licensing deals with THX Pharma. The drugmaker nabbed exclusive worldwide rights to Batten-1, an experimental treatment for juvenile Batten disease that's slated to enter Phase III testing this year; it's on track for a 2030 international launch.Biocodex also licensed US and Canadian rights for TX01 to treat Gaucher disease and Niemann-Pick type C disease. The programme is an adapted oral formulation of an already approved active substance.THX will receive €12 million ($14.3 million) upfront, and is eligible for up to €161 million ($191.5 million) in development and commercialisation milestone payments, plus double-digit tiered royalties. The company will be responsible for each asset's clinical development, while Biocodex will helm commercialisation activities in its respective territories. -Elizabeth EatonRivaroxaban combo axed from major US stroke trialThe US National Institutes of Health has halted one arm of a large clinical trial evaluating treatments to prevent strokes, after investigators determined that rivaroxaban combined with aspirin was linked to "an increase in safety events" and was unlikely to provide benefit over the current standard.The decision followed a routine review by an independent data safety and monitoring board overseeing the CAPTIVA study.The discontinued arm tested a low dose of the oral anticoagulant — marketed as Xarelto by Johnson & Johnson and Bayer — alongside daily aspirin in patients who had suffered a stroke attributed to stenosis of a major intracranial artery. CAPTIVA is enrolling up to 1683 participants and is designed to determine whether newer blood-thinning regimens outperform the current standard of care, clopidogrel plus aspirin.The study will now proceed by comparing ticagrelor, sold by AstraZeneca as Brilinta, plus aspirin against the clopidogrel-based standard therapy.-Anna Bratulic

The National Institutes of Health-funded Captiva study found that the combination of a low dose of Xarelto and aspirin was unlikely to help prevent recurrent strokes compared with standard of care in patients with narrowed brain arteries. The National Institutes of Health (NIH) halted a treatment arm of Bayer and Johnson & Johnson’s Xarelto (rivaroxaban) in a phase 3 stroke prevention trial after an independent committee flagged safety concerns and a lack of efficacy.The decision, announced Tuesday, follows a recommendation from a data safety and monitoring board, which found that the combination of a low dose of Xarelto and aspirin was unlikely to help prevent recurrent strokes compared with the standard of care in the phase 3 Captiva study.The board identified “an increase in safety events and evidence of futility,” the NIH—which funded the study—said in a Feb. 10 release. The release didn’t identify the specific safety signals.Xarelto’s current FDA label includes a boxed warning about increased risks of blood clots upon premature discontinuation. Anticoagulants like Xarelto may also cause serious bleeding.In the study, Xarelto was evaluated at a dose of 2.5 mg twice daily and was compared against clopidogrel (Plavix), both on top of aspirin. The trial has a second experimental arm evaluating AstraZeneca’s Brilinta and aspirin.The goal of the trial is to see whether either of the two blood-thinning regimens would be better than the current treatment to prevent another stroke in patients with narrowed brain arteries, which is one of the most common causes of stroke worldwide. The study is evaluating up to 1,683 participants, who are randomized 1:1:1 to receive one year of treatment with one of those three aspirin combo regimens.In a statement to Fierce Pharma, a J&J spokesperson said the discontinuation is “not related to any approved indications for Xarelto.” First approved by the FDA in 2011, Xarelto’s U.S. label includes its uses at 15 mg or 20 mg once daily to reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation. The regimen utilized in the Captiva study—2.5 mg Xarelto twice daily, in combination with aspirin—is approved by the FDA to reduce the risk of certain cardiovascular events, including stroke, in people with chronic coronary artery disease or peripheral artery disease.Generic versions of Xarelto are already available in the U.S. after Lupin and Taro Pharmaceuticals gained the first FDA approvals for their 2.5 mg copycats last year and launched immediately. Last year, Xarelto’s U.S. sales to J&J reached $2.6 billion, marking 11% growth compared with 2024. That said, the drug's fourth-quarter sales were roughly flat year over year.As Xarelto ages, J&J is shifting its focus to Bristol Myers Squibb-partnered factor XIa inhibitor milvexian, which is expected to report phase 3 results in secondary stroke prevention in the second half of 2026. J&J has predicted the new antithrombotic agent could reach more than $5 billion in peak annual sales. “What we’re really looking to show there is clear superiority in terms of safety and bleeding risk,” Jennifer Taubert, who leads J&J’s pharmaceuticals business, said about milvexian during the company’s fourth-quarter earnings call in January.“We know from all of our experience in the market with Xarelto that there are a lot of patients that are not treated or are undertreated because of fear of safety risk,” she continued. “So we think there’s extraordinary need for a highly efficacious and highly safe with low bleeding risk product in the market.”Editor's Note: The story was updated at 7:45 p.m. U.S. ET with a statement from J&J.