Hikma

The FDA on Thursday required new safety label updates for all opioids to “further emphasize and characterize the risks associated with long-term use,” following a May advisory committee meeting that discussed new postmarketing data. Specifically, the FDA told companies to pull the phrase “extended treatment period” in the Indications and Usage section of their labels, “to avoid misinterpretation that there are data to support safety and efficacy of opioid analgesics over an indefinitely long duration.” The updates also clarify that extended-release/long-acting opioids “should only be used” when alternatives, such as immediate-release opioids, “are inadequate to manage severe and persistent pain, and to emphasize the importance of avoiding rapid dose reduction or abrupt discontinuation in patients who may be physically dependent on opioid pain medicines,” the agency said in the update . In May, panelists on an FDA advisory committee offered mixed takes on whether the agency should update opioid labels with data from two required postmarketing studies. Some panelists found the studies’ findings difficult to interpret and not generalizable to current medical practice, since they were several years old. The FDA opted to add that information to the labels, which shows that over a 12-month period, approximately 1% to 6% of participants across the two postmarket groups newly met the criteria for addiction, and about 9% to 22% of participants newly met criteria for prescription opioid abuse and misuse. The FDA first approved extended-release/long-acting opioids in 1987. In 2013, it sought five additional postmarketing studies after concluding that more data were needed regarding the serious risks of misuse, abuse, addiction, overdose and death associated with long-term use. Allergan, Endo Pharmaceuticals, Hikma, Janssen, Mallinckrodt, Pfizer and Purdue Pharma were among those tasked with conducting the four observational studies and one prospective clinical trial. The agency also said it’s requiring label updates on which opioid overdose reversal agents are currently available. The FDA in March 2023 approved the first over-the-counter nasal spray version of naloxone, and in August 2024, FDA approved the first nalmefene hydrochloride auto-injector to treat opioid overdose in adults and children 12 years and older. Manufacturers must further “emphasize that higher doses are associated with increased risk of serious harm, and that the risks of serious harms persist over the course of therapy,” the FDA said.

The eight companies will together pay impacted states and governments up to $720 million, according to announcements from state attorneys general. Eight drugmakers agreed to put legal claims stemming from their roles in the U.S. opioid epidemic to rest with settlements that come out to a combined $720 million, according to Thursday press releases from numerous state attorneys general.Over timeframes ranging from a single year to ten years, Viatris agreed to fork over $284 million, while Amneal committed to $71.7 million in settlement payments and Apotex is on the hook for $63.7 million, according to a release from Pennsylvania's AG. Other companies involved in the settlements are Hikma ($95.8 million), Indivior ($38 million), Sun Pharma ($30.9 million), Alvogen ($18.7 million) and Zydus ($14.8 million).Viatris, which committed the biggest chunk in this group of settlements, previously disclosed a nationwide settlement framework that it hopes will “provide closure on these matters” and resolve opioid-related claims by states, local governments and Tribes against the company and its subsidiaries, the drugmaker said in an April press release. Depending on the level of participation in its settlement, Viatris agreed to pay up to a maximum of $335 million in annual payments over a nine-year period.Some drugmakers will also provide opioid addiction treatment medications under the deals, according to a press release from New York Attorney General Letitia James. Others will provide cash in lieu of those products. In addition, each company—besides Indivior—will be prohibited from marketing products that contain more than 40 mg of oxycodone per pill, according to Pennsylvania's AG. Indivior, for its part, will halt the manufacturing of opioid products for the next ten years but can continue selling treatments for opioid use disorder, according to the deal announcements.The settlements were moved along by “overwhelming participation” from AGs across the country, prompting all eight companies involved to move forward with a “sign-on period” for local governments to participate in the deals. North Carolina, California, Colorado, Illinois, New York, Oregon, Tennessee, Utah and Virginia were responsible for negotiating the deals.“While nothing can compensate for the lives lost and upended by the ongoing opioid crisis, I am grateful to secure these funds on behalf of Massachusetts residents who have been devastated by the crisis —funds that will meaningfully support opioid prevention, harm reduction, recovery, and more,” Massachusetts AG Joy Campbell said in a press release. The settlements are the latest in a wide-ranging web of litigation over the U.S. opioid epidemic. Last month, all 50 U.S. states plus Washington, D.C., and four U.S. territories agreed to sign on to a massive $7.4 billion settlement from Purdue Pharma and the Sackler family, its billionaire founding family.Other than the Sacklers, large opioid-related settlements have come from companies including Teva, Mallinckrodt, Endo and Amneal. In 2022, Johnson & Johnson and three drug distributors inked a landmark $26 billion settlement to resolve more than 3,000 lawsuits. 

Check back to this tracker for regulatory updates on marketed drugs, including expansions into new geographies and indications. Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Be sure to come back regularly for the latest updates.UPDATED: Wednesday, July 2 at 10:30 a.m. ETA little over a year after Merck & Co. scored U.S. approval for its pulmonary arterial hypertension (PAH) newcomer Winrevair (sotatercept), the New Jersey drugmaker has locked in an expedited review timeline to potentially update the medicine’s label.The FDA has granted priority review to Merck’s application and set a target date of Oct. 25 to decide whether to revise Winrevair’s label with impressive morbidity and mortality data from Merck’s phase 3 ZENITH trial.The study, which was the first late-stage PAH outcomes trial to leverage a primary endpoint consisting of major morbidity and mortality events, recently stopped early on the advice of a third-party data monitoring committee thanks to “overwhelming efficacy,” Merck noted in a July 2 press release.In the trial, Winrevair led to a 76% reduction in the risk of a composite of all-cause death, lung transplantation and hospitalization in PAH patients for at least 24 hours compared to placebo.Winrevair was approved by the FDA last March as an add-on therapy to standard of care in a subset of PAH patients defined by the World Health Organization (WHO). Merck picked up the drug in its $11.5 billion acquisition of Acceleron. Analysts have predicted peak sales of Winrevair could land anywhere between $2 billion and $4 billion. Over in Europe, Vertex Pharmaceuticals is continuing to grow its cystic fibrosis (CF) empire with a European Commission (EC) approval of its once-a-day triple therapy Alyftrek—comprising deutivacaftor, tezacaftor and vanzacaftor—in CF patients ages 6 years and older who have at least one non-class 1 mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.The EC gave its blessing after reviewing data from two head-to-head studies that found Alyftrek was non-inferior to Vertex’s entrenched CF therapy Kaftrio in combination with ivacaftor on a standard measure of lung function and superior when it came to reducing sweat chloride and spurring greater improvements in CFTR function.The EC green light significantly expands the reach of Vertex’s CF therapeutics overseas, with some 31,000 CF patients in the European Union (EU) now eligible to receive the new therapy, the company pointed out.The drug is expected to launch in Ireland, Denmark and Germany first as Vertex continues to work out reimbursement deals with other EU member states.The thumbs up from the EC comes after the FDA cleared Alyftrek in a similar patient population in late December. Elsewhere, London-based Hikma has won the FDA’s blessing for a new, ready-to-infuse formulation of the antibiotic vancomycin for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections in adults and children as young as 1 month or older.Hikma will market the novel formulation of the well-established anti-infective under the commercial moniker Tyzavan, which the company says stands for “time-saving vancomycin.”The green light earns Tyzavan the distinction of being the only vancomycin product that can be kept at room temperature and doesn’t require compounding, thawing, activation or dilution before use, which ought to hasten treatment by reducing preparation steps, Hikma said in a July 2 press release.U.S. sales of injectable vancomycin approached $200 million in 2024, Hikma noted, citing data from the health information and research firm IQVIA.