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: Friday, July 11 at 8:50 a.m. ET
After a review by the safety committee of the European Medicines Agency, the regulator is removing a temporary restriction on Valneva's chikungunya vaccine.
Back in May, the regulator recommended against the continued use of the vaccine, Ixchiq, in people 65 and older as it weighed reports of serious adverse events in elderly people.
Now, EMA says the shot should only be given "when there is a significant risk of chikungunya infection and after a careful consideration of the benefits and risks."
Serious side effects have been seen "mainly in people 65 years and older and in those with several underlying medical conditions," the agency said in a July 11 announcement.
While there is a side effect risk for some, the vaccine remains "effective at triggering the production of antibodies against the chikungunya virus which may be of particular benefit for older people who are at increased risk of severe chikungunya infection," the EMA said.
In the U.S., authorities recommended a pause of the vaccine rollout in people 60 and older in May. At the time, U.S. officials said there had been 17 reports of serious adverse events, including 2 deaths, in Ixchiq recipients ages 62 to 89 around the world.
Moderna's COVID-19 vaccine, Spikevax, has picked up a full U.S. approval in children aged 6 months to 11 years who are at an increased risk from the disease.
The vaccine was previously available for these children under an Emergency Use Authorization, Moderna noted in a July 10 press release.
With the nod, the vaccine is available to people 6 months to 64 years of age who are at a high risk for severe disease, and for everyone 65 and older.
UPDATED: Thursday, July 10 at 9:55 a.m. ET
Three months after winning a thumbs up from the U.K.’s drug regulator in Crohn's disease, Eli Lilly’s Omvoh (mirikizumab) has scored the blessing of the nation’s drug cost watchdog.
The National Institute for Health and Care Excellence (NICE) has signed off on Omvoh in moderately to severely active Crohn’s in adults under three potential conditions: Patients will be able to access the treatment if their disease didn’t respond well enough or stopped responding to a previous biologic therapy; if a previous biologic drug wasn’t well tolerated; or if tumor necrosis factor (TNF)-alpha inhibitors are not suitable for that patient, according to final draft guidance published on July 10.
While “indirect comparisons of mirikizumab with other biological treatments are uncertain,” there is sufficient evidence—bolstered by clinical expert opinion—that “mirikizumab is likely to work as well as risankizumab,” NICE said of the recommendation, referring to the generic name for AbbVie’s Skyrizi.
Now that the U.K.’s drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), and NICE have aligned on Omvoh, the drug will be made available as a treatment option for patients in England and Wales within 30 and 60 days, respectively, Pharmaphorum noted on Thursday.
Aside from AbbVie’s Skyrizi, Omvoh will also be sharing the U.K. Crohn’s market with Takeda’s Entyvio (vedolizumab) and Johnson & Johnson’s Stelara (ustekinumab), the latter of which also has biosimilar versions available in the country.
NICE has also endorsed the BTK inhibitor Brukinsa (zanubrutinib) from BeOne Medicines—formerly known as BeiGene—in relapsed or refractory mantle cell lymphoma (MCL). The vote of confidence specifically covers the use of BeOne’s drug in adults who’ve had one prior line of treatment.
Patients with relapsed or refractory MCL seeking additional treatment after first-line therapy typically turn to AbbVie’s Imbruvica (ibrutinib). Brukinsa “works in a similar way” and “would be offered to a similar population” under the recommendation, NICE pointed out in its guidance. NICE did caveat that data from an indirect comparison between Brukinsa and Imbruvica are “uncertain because of differences between the people in the included trials.”
NICE has previously recommended BeOne’s drug in certain patients with Waldenstrom’s macroglobulinemia, as well as those with chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL).
BeOne has also secured a green light for its PD-1 inhibitor Tevimbra (tislelizumab) in the European Union.
The approval, finalized by the European Commission (EC), covers the use of Tevimbra alongside the chemotherapy drugs gemcitabine and cisplatin for initial treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC).
The EC based its decision on BeOne’s late-stage RATIONALE-309 study, in which the Tevimbra-chemotherapy cocktail reduced the risk of disease progression or death by 48% at the time of the trial’s first interim analysis. Median progression-free survival (PFS) for patients on the Tevimbra regimen clocked in at 9.2 months, versus 7.4 months for patients on placebo plus gemcitabine and cisplatin, BeOne said in a July 10 press release.
Those results were reinforced by data from an additional 12 months of follow-up in the trial, in which patients on the Tevimbra cocktail achieved a median overall survival (OS) of 45.3 months, compared to 31.8 months for patients in the study’s control cohort.
Tevimbra also boasts EU approvals in gastric or gastroesophageal junction adenocarcinoma, unresectable esophageal squamous cell carcinoma, extensive-stage small cell lung cancer and three separate non-small cell lung cancer indications.
Meanwhile, over in China, Ascentage Pharma has landed an approval for its B-cell lymphoma 2 (Bcl-2) selective inhibitor lisaftoclax in adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who’ve previously tried at least one prior therapy, including BTK inhibitors.
With the green light, lisaftoclax becomes the second Bcl-2 inhibitor approved globally behind AbbVie’s Venclexta (venetoclax) and the first approved in China for patients with CLL/SLL, Ascentage said on July 10.
China’s National Medical Products Administration (NMPA) endorsed the drug after reviewing data from a pivotal phase 2 study looking at overall response rate (ORR) as the primary endpoint. Lisaftoclax displayed “compelling efficacy” and charted an ORR that satisfied the study’s main objective in patients previously treated with BTK inhibitors or immunochemotherapy, Ascentage noted in its release.
UPDATED: Tuesday, July 8 at 9:20 a.m. ET
A little over half a year after acquiring central nervous system specialist Intra-Cellular Therapies, Johnson & Johnson is advancing plans for its newly inherited schizophrenia medicine Caplyta.
J&J has submitted a supplemental new drug application to the FDA leveraging positive data on Caplyta’s (lumateperone’s) ability to prevent relapse in schizophrenia patients. The company based its filing on a phase 3 withdrawal study, which showed that patients on Caplyta took significantly longer to experience symptom relapse than those on placebo during a 26-week treatment phase.
Patients on Caplyta also experienced a 63% reduction in the risk of relapse versus placebo, J&J said in a July 8 press release. Further, Caplyta helped significantly delay time to all-cause discontinuation, including relapse, compared to the dummy drug.
Relapses in schizophrenia refer to the recurrence of symptoms like psychosis, hallucinations and other disruptive behaviors. On average, adults with schizophrenia experience nine relapses in less than six years, J&J noted in its release.
"Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder," Bill Martin, Ph.D., the global therapeutic leader for neuroscience at Johnson & Johnson Innovative Medicine, said in a statement.
Caplyta is currently approved in the U.S. for the treatment of schizophrenia in adults, and as a treatment for depressive episodes linked to bipolar 1 or 2 disorder.
Across the pond, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization to ImmunityBio’s lymphocyte-stimulating agent, Anktiva, in combination with the Bacillus Calmette-Guérin (BCG) vaccine, to treat BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS).
The green light marks the second in the world for Anktiva after the FDA approved the drug in a similar bladder cancer indication last April.
Anktiva functions as an IL-15 agonist that activates and proliferates natural killer (NK) cells, plus CD4+ and CD8+ T cells. The drug is designed to restore immune competence by reversing lymphopenia, wherein cancer and conventional cancer therapies like chemotherapy, radiation and checkpoint inhibitors curb the number of a patient’s immune cells and blunt their function, ImmunityBio explained in its approval announcement.
ImmunityBio estimates that there are around 16,400 to 18,000 patients diagnosed with NMIBC in the U.K. each year. With approvals secured in the U.S. and the U.K., ImmunityBio is next jockeying for a greenlight from the European Medicines Agency (EMA). An EMA thumbs up would allow ImmunityBio to market its therapy across all 27 European Union member states, plus Iceland, Norway and Liechtenstein.
UPDATED: Wednesday, July 2 at 10:30 a.m. ET
A 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.